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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Atypical Antipsychotics Tied to Adrenal Issues
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
NEW ORLEANS — It is important to recognize the potential for atypical antipsychotics to cause adrenal insufficiency to ensure that the condition is managed appropriately, according to Dr. Violeta Tan and Dr. Natalie Rasgon.
They described the case of a 54-year-old man with a history of depression and posttraumatic stress disorder who was admitted to the hospital after complaining of malaise 9 days after a previous admission for a urinary tract infection that had been treated with ciprofloxacin.
At the first admission, the patient was restarted on 225 mg/day of bupropion and 300 mg/day of quetiapine (Seroquel), both of which he had discontinued 6–8 months prior, said Dr. Tan and Dr. Rasgon, who presented the case in a poster session at the American Psychiatric Association's Institute of Psychiatric Services.
Symptoms at the time of the second admission included fatigue, warmth, chills, loose stools, mild headache, and reproducible chest wall pain. Laboratory findings showed that previously normal eosinophil levels were elevated (6.5%–8.3%), reported Dr. Tan and Dr. Rasgon, both of Stanford (Calif.) University.
A work-up for infection, malignancy, and rheumatologic conditions was negative, and primary adrenal insufficiency was ruled out based on the findings of a cosyntropin stimulation test. However, adrenocorticotropic hormone (ACTH) levels (less than 5 pg/mL) indicated secondary or tertiary adrenal insufficiency, and a review of the patient's medications alerted the authors to the possibility of quetiapine-associated ACTH and cortisol reductions.
Atypical antipsychotics such as quetiapine can reduce cortisol levels—often in association with improved psychopathology. Thus, although the cortisol-lowering effects of such drugs may ameliorate negative symptomatology, the reduction could be detrimental, they wrote.
However, adrenal insufficiency caused by such agents has not been specifically studied, and although it might seem appropriate to discontinue the “offending agent,” the risks of discontinuing antipsychotics should be weighed against the benefits of preventing adrenal insufficiency sequelae, they added.
In the current case, which also demonstrated that quetiapine administration, particularly under precipitating circumstances such as an infection or stress, can contribute to reductions in ACTH and cortisol secretion, the patient's condition improved after quetiapine, a standard treatment for adrenal insufficiency, was administered at 20 mg every morning and at 10 mg at bedtime.
Atypical antipsychotics can cause adrenal insufficiency, which presents ambiguously, and awareness of this can be key in preventing false diagnoses, they said.
Adrenal insufficiency can present ambiguously, which can lead to false diagnoses. DR. RASGON
Spotting Adrenal Insufficiency
Dr. Tan and Dr. Rasgon say determining whether a patient has developed adrenal insufficiency requires an investigation into four areas:
▸ Symptoms. Look for weakness and fatigue, abdominal distress, anorexia, nausea, vomiting, myalgia or arthralgia, postural dizziness, salt craving, headache, impaired memory, and depression.
▸ Physical findings. Some factors to look out for are increased pigmentation, postural hypotension, tachycardia, fever, decreased body hair, vitiligo, amenorrhea, and cold intolerance.
▸ Laboratory findings. Red flags include hyponatremia, hyperkalemia, hypoglycemia, eosinophilia, and elevated thyroid stimulating hormone.
▸ Clinical problems. Watch for hemodynamic instability, ongoing inflammation, multiple-organ dysfunction, and hypoglycemia.
FDA Advisory Panel Votes NO on Belantamab for Myeloma
A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.
ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.
“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.
Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”
Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).
The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.
Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.
Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.
Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.
“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.
Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.
John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”
“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.
The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.
A version of this article first appeared on Medscape.com.
A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.
ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.
“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.
Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”
Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).
The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.
Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.
Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.
Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.
“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.
Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.
John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”
“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.
The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.
A version of this article first appeared on Medscape.com.
A bid by GlaxoSmithKline (GSK) to bring its multiple myeloma drug belantamab mafodotin (Blenrep) back to the market hit a stumbling block during an FDA panel meeting held on July 17.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against belantamab in combination with bortezomib and dexamethasone and 7-1 against belantamab in combination with pomalidamide and dexamethasone on the specific questions of whether the benefits of each treatment regimen at the proposed doses outweigh the risks for patients with relapsed or refractory disease after at least one prior line of therapy.
ODAC members voting no cited concerns about the lack of exploration of optimal dosing, as well as high rates of ocular toxicity and a lack of diversity among trial participants.
“This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of New York University Langone Health in New York City.
Regarding optimal dosing, Vasan, who voted no on both questions, cited “a missed opportunity over the course of many years during the development of this drug to explore these different dosages,” but he also noted that “the building blocks are here to explore this question in the future.”
Belantamab, an antibody-drug conjugate targeting B-cell maturation antigen, was granted accelerated approval as a late-line therapy for relapsed or refractory multiple myeloma in August 2020 based on findings from the DREAMM-2 trial. However, GSK voluntarily withdrew the drug from the US market in 2023 after the confirmatory DREAMM-3 trial did not meet its primary endpoint of improved progression-free survival (PFS).
The company continued to explore belantamab in combination with other agents and in earlier lines of therapy. Based on findings from the DREAMM-7 and DREAMM-8 trials, which both showed improved PFS vs standard-of-care triplet therapies, the company submitted a new Biologics License Application in November 2024 seeking approval of the belantamab-based regimens.
Findings from DREAMM-7 and DREAMM-8 were reported at the 2025 American Society of Clinical Oncology conference in Chicago in June.
Both studies met their primary PFS endpoints, but the FDA expressed concerns about adverse events, dosing, and the relevance of the data for US patients and therefore sought input from ODAC members on the proposed dosages of 2.5 mg/kg every 3 weeks for the belantamab plus bortezomib and dexamethasone combination and 2.5 mg/kg in cycle 1, followed by 1.0 mg/kg every 4 weeks for the belantamab plus pomalidamide and dexamethasone combination.
Although GSK and several patients with multiple myeloma touted life-saving benefits of belantamab and argued that ocular toxicity associated with treatment is manageable and transient, most — but not all — ODAC members were unconvinced, at least as to the immediate questions regarding the benefit-risk profile.
“This is probably one of the most difficult votes I’ve done as a member of this committee,” said Grzegorz S. Nowakowski, MD, of the Mayo Clinic, Rochester, Minnesota, who voted yes on belantamab plus bortezomib and dexamethasone.
Nowakowski noted mistakes made from a regulatory perspective, including a lack of appropriate US patient representation in the trials and attention to dose optimization, but ultimately said that, as a practicing hematologist, he couldn’t ignore the drug’s clear activity, including a possible overall survival benefit, and the potential for mitigating toxicity with careful follow-up and dose reductions.
John DeFlice, MD, of Cedars-Sinai Samuel Oschin Cancer Center in Los Angeles — a multiple myeloma survivor and patient representative on the committee — voted yes on both questions, noting that, based on the testimony of patients and the clinical experience of the investigators, belantamab is “an amazing drug for an incurable disease.”
“I think [these] are the wrong issues to be evaluated,” DeFlice said of the specific questions posed by the FDA at the hearing.
The FDA considers the recommendations of its advisory panels in making final approval decisions but is not bound by them.
A version of this article first appeared on Medscape.com.
Many Early-Onset Cancers Increasing, Particularly in Women
Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found.
Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.
Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma.
Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.
The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019.
First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.
Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).
Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year.
The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.
For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.
Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.
Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”
This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.
The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.
“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”
This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.
version of this article first appeared on Medscape.com.
Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found.
Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.
Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma.
Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.
The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019.
First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.
Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).
Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year.
The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.
For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.
Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.
Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”
This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.
The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.
“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”
This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.
version of this article first appeared on Medscape.com.
Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found.
Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.
Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma.
Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.
The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019.
First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.
Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).
Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year.
The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.
For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.
Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.
Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”
This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.
The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.
“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”
This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.
version of this article first appeared on Medscape.com.
Radiation Oncology Reimbursement: New Bill Rocks the Boat
A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.
In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field.
The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill.
However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.
“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill.
But, Basree acknowledged, “not everybody likes the bill.”
A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”
Impetus for the Bill
Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform.
Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement.
A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.
These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation.
These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.
The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year.
What Is the ROCR Act?
The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement.
In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.
When first introduced last year, the bill did not receive a vote in Congress.
A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.
Mixed Reactions
How has the radiation oncology community reacted to the latest ROCR Act?
A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.
“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.
Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed.
While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.
The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.
ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said.
And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.
“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained.
The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.
But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”
Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.
“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added.
Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.
ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.”
The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said.
“I believe in this bill,” Basree added.
Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.
Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.
Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.
Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.
In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field.
The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill.
However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.
“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill.
But, Basree acknowledged, “not everybody likes the bill.”
A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”
Impetus for the Bill
Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform.
Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement.
A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.
These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation.
These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.
The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year.
What Is the ROCR Act?
The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement.
In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.
When first introduced last year, the bill did not receive a vote in Congress.
A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.
Mixed Reactions
How has the radiation oncology community reacted to the latest ROCR Act?
A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.
“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.
Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed.
While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.
The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.
ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said.
And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.
“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained.
The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.
But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”
Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.
“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added.
Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.
ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.”
The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said.
“I believe in this bill,” Basree added.
Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.
Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.
Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.
Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
A renewed effort to modernize and stabilize Medicare reimbursement for radiation therapy services is underway.
In mid-March, members of Congress reintroduced bipartisan federal legislation that would shift Medicare reimbursement for radiation oncology services from quantity-based payments to episode-based payments and help stabilize the declining rates of reimbursement in the field.
The Radiation Oncology Case Rate (ROCR) Value Based Payment Program Act, sponsored by two senators and four representatives, would not only “transform” how Medicare reimburses radiation therapy services, it would also “protect access to high quality cancer care and improve outcomes for patients nationwide, while generating savings for Medicare,” according to a recent American Society for Radiation Oncology (ASTRO) press release praising the bill.
However, the reaction among those in the field has been mixed. Whereas some radiation oncologists are aligned with the bill, others argue that the legislation was crafted without meaningful input from many who will be affected.
“There’s consensus across multiple groups within the house of radiation oncology, hospital groups, and industry, which is incredibly important,” according to Mustafa Basree, DO, a radiation oncology resident who serves on ASTRO’s government relations committee and was part of the discussion on drafting the bill.
But, Basree acknowledged, “not everybody likes the bill.”
A core complaint is a lack of communication and input from clinicians in the field. “If we’re going to decide to design our own quality program — which is really like a dream from a clinician’s standpoint — we need a meaningful way to come together as a unified field,” said Matthew Spraker, MD, PhD, a radiation oncologist practicing in Denver. In this bill, “we’re not getting any of that.”
Impetus for the Bill
Amid dramatic drops in Medicare reimbursement — and with more probably on the horizon — ASTRO announced in January 2024 that the society had partnered with the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology to lobby for payment reform.
Cuts to Medicare reimbursement were approaching 25% at the time. These declines were related, in part, to changes in how radiation treatment was being delivered. Reimbursement has historically been based on the fraction of radiation given, but the field has increasingly embraced hypofractionated regimens and deescalated approaches, which have led to fewer billable fractions and consequently lower reimbursement.
A recent study highlighted significant declines in reimbursement based on this shift in care. For instance, greater use of hypofractionation led to declines in reimbursement for technical services in freestanding radiation oncology offices by nearly 17% for breast cancer and 14.2% for prostate cancer between 2016 and 2022. Inflation-adjusted Medicare conversion factors fell 12.2% in hospital outpatient centers and 20.8% in freestanding offices.
These declining reimbursement rates have occurred alongside changes to radiation oncology practice patterns. A recent analysis reported a 51% increase in the number of US practices with at least 10 radiation oncologists between 2015 and 2023, and a 27% decrease in the number of solo practices during the same period. The number of practicing radiation oncologists increased by 16%, but the number of practices employing them decreased by 13%, indicating a trend toward practice consolidation.
These changes, the analysis found, may affect patients’ access to care. In rural areas, retirement rates were higher and rates of entry of new radiation oncologists was lower compared with urban areas.
The current payment structure “has become untenable,” leading to practice consolidation that threaten patient access, especially in rural and underserved areas, a spokesperson for ASTRO told this news organization last year.
What Is the ROCR Act?
The ROCR ACT was drafted by ASTRO to address these issues and reverse declines in Medicare reimbursement.
In addition to shifting radiation oncology reimbursement from fraction-based to episode-based, the bill also aims to encourage clinicians to adoptevidence-based shorter treatment regimens, improve safety and quality by supporting new technologies, and generate savings to Medicare by eliminating outdated and costly practices that have not been shown to improve patient outcomes.
When first introduced last year, the bill did not receive a vote in Congress.
A 2025 version of the bill, introduced last month, largely aligns with the 2024 legislation but contains some “enhancements,” such as improving accreditation with increased incentive payments, outlining a revised exemption for practices with limited resources and instituting a transitional payment period for adaptive radiation therapy to allow billing to continue while a new code is created.
Mixed Reactions
How has the radiation oncology community reacted to the latest ROCR Act?
A recent survey, which included more than 500 practicing radiation oncologists, found that 61% of respondents supported implementing an episode-based payment model such as that proposed in the 2025 legislation, 17.3% neither supported nor opposed it, and 21.6% opposed the model.
“I think this supports this idea that our field would have benefited from much more open discussion in the design phases of the bill,” Spraker told this news organization.
Jason Beckta, MD, PhD, a radiation oncologist at Rutland Regional Medical Center, Vermont, agreed.
While on board with the concept of reform and episode-based payment, given what Beckta called “the absolute absurdity of the cuts in radiation oncology,” he took issue with the lack of transparency in the rollout of the bill.
The announcement about the 2025 version of the ROCR Act came as “a complete surprise — out of nowhere — except to insiders,” Beckta said.
ASTRO held a town hall in February 2025 “featuring new information and discussion” regarding ROCR 2025, but the bill had already been finalized for submission at that point, Beckta said.
And although Beckta and Spraker believe ASTRO had good intentions, the physicians highlighted concerns with several aspects of the bill.
“What upsets me most is the blatant regulatory capture,” Beckta said. The legislation will require all practices to be accredited by either ASTRO, the American College of Radiation Oncology, or the American College of Radiology, essentially capturing their business through a regulation or having practices “face a 2.5% penalty, which is up 1% from the prior version,” Beckta explained.
The bill also shortens the runway to get accredited from 3 years to 2 years, Beckta noted, stressing the arduousness of the accreditation process as a hurdle for many practices.
But doing the accreditation program does not mean care will get better, Spraker said. In fact, “that is absolutely not the case.”
Another issue: Requirements for medical equipment and quality review periods seem to favor industry over patients and practices, he said, highlighting the potential role of manufacturers in determining if or when equipment updates are required.
“A field like ours has rapidly exploding technology with not-always-clear patient benefit,” said Spraker. “We’re seeing too many examples where people are leveraging that, basically to sell devices instead of to help patients,” he added.
Furthermore, Beckta noted, the bill allows for reduced reimbursement of between 4% and 7%, depending on the circumstances — a cut to reimbursement that is being justified by saying it’s the only way the bill will get through Congress. But “it’s just a less-bad option than continued cuts to fee-for-service,” Beckta said.
ASTRO leadership has expressed strong support for the bill. In the recent ASTRO press release, Howard M. Sandler, MD, chair of the ASTRO Board of Directors, called the ROCR Act “the only viable policy solution designed to provide payment stability for the field of radiation oncology in 2026 and beyond.”
The ROCR Act, which is broadly supported by more than 80 organizations, “represents a balanced, evidence-based policy solution to safeguard access to high value cancer treatment for Americans,” Sandler said.
“I believe in this bill,” Basree added.
Basree touted the replacement of a fee-for-service model with a “value-based payment system, ensuring predictable, fair reimbursement for the field” as a major win for stabilizing Medicare reimbursement. The bill also includes measures to improve patient access, such as providing discounted transportation for patients — a significant need, particularly in rural areas, he explained.
Although not everyone is happy with the bill, ASTRO did aim “to build coalition of support,” Basree said. “It’s an uphill battle, for sure, but we should press forward and hope for the best,” he added.
Even with their concerns, both Spraker and Beckta are optimistic that improvements to the bill can still be made, and urge colleagues to study the bill, speak out, and engage to help promote the best possible policy.
Basree reported receiving reimbursement for meeting travel and lodging as both a Fellow and member of the Association of Residents in Radiation Oncology. Spraker and Beckta reported having no relevant disclosures.
A version of this article first appeared on Medscape.com.
FDA Approves Sotorasib + Panitumumab for mCRC
The US Food and Drug Administration (FDA) has approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for the treatment of certain adult patients with metastatic colorectal cancer (mCRC).
Specifically, the combination therapy is indicated for those with KRAS G12C-mutated mCRC, as determined using an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, according to the FDA notice. The FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device for identifying eligible patients.
Approval of sotorasib with panitumumab was based on findings from the randomized, open-label, controlled CodeBreaK 300 trial showing improved overall response rates (ORR) and progression-free survival (PFS) with sotorasib and panitumumab vs investigator’s choice of trifluridine/tipiracil or regorafenib, which are current standard-of-care options.
Median PFS was 5.6 months in 53 patients randomized to receive 960 mg of oral sotorasib once daily plus 6 mg/kg of intravenous (IV) panitumumab every 2 weeks, and 2 months in 54 patients randomized to receive standard-of-care therapy (hazard ratio, 0.48). The ORR was 26% vs 0% in the arms, respectively, and the duration of response in the sotorasib/panitumumab arm was 4.4 months. No significant difference in PFS was observed between the standard-of-care arm and a third arm with 53 patients who received 240 mg of oral sotorasib daily plus 6 mg/kg of IV panitumumab every 2 weeks.
Overall survival (OS) did not differ significantly between the treatment arms in the final analysis, but the study was not statistically powered for OS.
Adverse reactions occurring in at least 20% of patients receiving sotorasib/panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. Common grade 3-4 laboratory abnormalities, which occurred in two or more patients, included decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium.
The recommended dose of sotorasib is 960 mg given orally once daily and administered before the first panitumumab infusion. The recommended panitumumab dose is 6 mg/kg as an IV infusion every 14 days until disease progression, unacceptable toxicity, or until sotorasib is withheld or discontinued, according to the full prescribing information.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for the treatment of certain adult patients with metastatic colorectal cancer (mCRC).
Specifically, the combination therapy is indicated for those with KRAS G12C-mutated mCRC, as determined using an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, according to the FDA notice. The FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device for identifying eligible patients.
Approval of sotorasib with panitumumab was based on findings from the randomized, open-label, controlled CodeBreaK 300 trial showing improved overall response rates (ORR) and progression-free survival (PFS) with sotorasib and panitumumab vs investigator’s choice of trifluridine/tipiracil or regorafenib, which are current standard-of-care options.
Median PFS was 5.6 months in 53 patients randomized to receive 960 mg of oral sotorasib once daily plus 6 mg/kg of intravenous (IV) panitumumab every 2 weeks, and 2 months in 54 patients randomized to receive standard-of-care therapy (hazard ratio, 0.48). The ORR was 26% vs 0% in the arms, respectively, and the duration of response in the sotorasib/panitumumab arm was 4.4 months. No significant difference in PFS was observed between the standard-of-care arm and a third arm with 53 patients who received 240 mg of oral sotorasib daily plus 6 mg/kg of IV panitumumab every 2 weeks.
Overall survival (OS) did not differ significantly between the treatment arms in the final analysis, but the study was not statistically powered for OS.
Adverse reactions occurring in at least 20% of patients receiving sotorasib/panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. Common grade 3-4 laboratory abnormalities, which occurred in two or more patients, included decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium.
The recommended dose of sotorasib is 960 mg given orally once daily and administered before the first panitumumab infusion. The recommended panitumumab dose is 6 mg/kg as an IV infusion every 14 days until disease progression, unacceptable toxicity, or until sotorasib is withheld or discontinued, according to the full prescribing information.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for the treatment of certain adult patients with metastatic colorectal cancer (mCRC).
Specifically, the combination therapy is indicated for those with KRAS G12C-mutated mCRC, as determined using an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, according to the FDA notice. The FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device for identifying eligible patients.
Approval of sotorasib with panitumumab was based on findings from the randomized, open-label, controlled CodeBreaK 300 trial showing improved overall response rates (ORR) and progression-free survival (PFS) with sotorasib and panitumumab vs investigator’s choice of trifluridine/tipiracil or regorafenib, which are current standard-of-care options.
Median PFS was 5.6 months in 53 patients randomized to receive 960 mg of oral sotorasib once daily plus 6 mg/kg of intravenous (IV) panitumumab every 2 weeks, and 2 months in 54 patients randomized to receive standard-of-care therapy (hazard ratio, 0.48). The ORR was 26% vs 0% in the arms, respectively, and the duration of response in the sotorasib/panitumumab arm was 4.4 months. No significant difference in PFS was observed between the standard-of-care arm and a third arm with 53 patients who received 240 mg of oral sotorasib daily plus 6 mg/kg of IV panitumumab every 2 weeks.
Overall survival (OS) did not differ significantly between the treatment arms in the final analysis, but the study was not statistically powered for OS.
Adverse reactions occurring in at least 20% of patients receiving sotorasib/panitumumab were rash, dry skin, diarrhea, stomatitis, fatigue, and musculoskeletal pain. Common grade 3-4 laboratory abnormalities, which occurred in two or more patients, included decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium.
The recommended dose of sotorasib is 960 mg given orally once daily and administered before the first panitumumab infusion. The recommended panitumumab dose is 6 mg/kg as an IV infusion every 14 days until disease progression, unacceptable toxicity, or until sotorasib is withheld or discontinued, according to the full prescribing information.
A version of this article first appeared on Medscape.com.
Daratumumab Confirmed as SOC for AL Amyloidosis
Adding DARA to VCd (D-VCd; Darzalex Faspro; Janssen Biotech) provided deeper and more rapid hematologic response and clinically meaningful and statistically significant improvement in overall survival (OS) and major organ deterioration progression-free survival (MOD-PFS), combined with 40.7% cardiac complete response (CR), first author Efstathios Kastritis, MD, said during presentation of an oral abstract at the American Society of Hematology (ASH) 2024 Annual Meeting.
“The Andromeda study is the first comparing two contemporary regimens that shows a significant survival improvement for patients with AL amyloidosis,” said Kastritis, an associate professor at the National and Kapodistrian University of Athens in Greece. “These findings reaffirm frontline D-VCd as the standard of care in this difficult-to-treat disease.”
The regimen was approved for this indication in 2021 based on prior earlier findings from the Andromeda trial. The current results are from a preplanned analysis for MOD-PFS and OS.
At a median follow-up of 61.4 months, the overall hematologic CR rates were 59.5% and 19.2% among 388 patients randomized to receive D-VCd or VCd, respectively (odds ratio, 6.03), which showed continued improvement with additional DARA vs the 53.3% and 18.1% rates observed at the primary analysis, Kastritis reported.
Time to hematologic CR was 67.5 days and 85.0 days in the treatment groups, respectively, and median duration of hematologic CR was not reached in either group.
A significant 56% improvement was also observed in MOD-PFS (hazard ratio [HR], 0.44). Median MOD-PFS was not reached in the D-VCd group and was 30.3 months in the VCd group.
A significant 38% improvement was observed in OS (HR, 0.62), 5-year OS was 76.1% vs 64.7% in the D-VCd and VCd groups, respectively, he said.
“[The OS] benefit occurred even though more than 70% of the patients in the VCd arm who received a subsequent therapy were treated with a DARA-based regimen,” he stressed. “This further emphasizes the importance of using DSTS in the frontline setting.”
Trial participants had newly diagnosed AL amyloidosis with measurable hematologic disease, one or more involved organs, cardiac stage I-IIIA, estimated glomerular filtration rate of at least 20 mL/min, and absence of symptomatic multiple myeloma. They were randomized 1:1 to the two treatment groups. All patients received 1.3 mg/m2 of bortezomib by weekly injection, 300 mg/m2 of cyclophosphamide either by weekly oral or intravenous administration, and 20-40 mg of dexamethasone by weekly oral or intravenous administration for six 28-day cycles.
Those in the D-VCd group also received 1800 mg of DARA coformulated with rHuPH20 as a weekly injection in cycles 1-2, as a biweekly injection in cycles 3-6, and by injection every 4 weeks thereafter for up to 24 28-day cycles.
The median duration of treatment was 21.3 months for D-VCd and 5.3 months for VCd, and of 122 patients who received subsequent therapy, 82 (67%) received subsequent DARA.
Patients who achieved hematologic CR had better MOD-PFS and OS (HR, 0.30 and 0.41, respectively), regardless of the treatment received, he noted, adding that “this further supports that complete hematologic response is a valid early endpoint for the evaluation of anti-monoclonal therapies in AL amyloidosis.”
“I think this is very important for the further development of new treatments in this disease,” he said.
Of note, cardiac and renal response rates in the D-VCd group were about two to three times greater than those in the VCd group at 6, 12, 24, 36, and 48 months, Kastritis said.
Among 235 patients with an evaluable cardiac response, 113 achieved a very good partial response or better, including 76 of 118 (64.4%) in the D-VCd group and 37 of 117 (31.6%) in the VCd group. Of these, 48 (40.7%) and 16 (13.7%) achieved a cardiac CR.
Grade 3 or 4 treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients in the D-VCd and VCd groups, respectively, were lymphopenia (13% and 10%), pneumonia (8% and 4%), hypokalemia (2% and 5%), and peripheral edema (3% and 6%), he noted, adding that systemic administration-related reactions occurred in 14 (7%) of patients receiving D-VCd; all were grade 1 or 2 and most (86%) occurred after the first injection. TEAEs led to treatment discontinuation in 5% and 4% of patients in the groups, respectively.
No new safety signals were observed during the extended follow-up, he said.
Kastritis reported relationships with Pfizer, Genesis Pharma, Sanofi, AbbVie, GSK, Prothena, Janssen, and Amgen.
A version of this article first appeared on Medscape.com.
Adding DARA to VCd (D-VCd; Darzalex Faspro; Janssen Biotech) provided deeper and more rapid hematologic response and clinically meaningful and statistically significant improvement in overall survival (OS) and major organ deterioration progression-free survival (MOD-PFS), combined with 40.7% cardiac complete response (CR), first author Efstathios Kastritis, MD, said during presentation of an oral abstract at the American Society of Hematology (ASH) 2024 Annual Meeting.
“The Andromeda study is the first comparing two contemporary regimens that shows a significant survival improvement for patients with AL amyloidosis,” said Kastritis, an associate professor at the National and Kapodistrian University of Athens in Greece. “These findings reaffirm frontline D-VCd as the standard of care in this difficult-to-treat disease.”
The regimen was approved for this indication in 2021 based on prior earlier findings from the Andromeda trial. The current results are from a preplanned analysis for MOD-PFS and OS.
At a median follow-up of 61.4 months, the overall hematologic CR rates were 59.5% and 19.2% among 388 patients randomized to receive D-VCd or VCd, respectively (odds ratio, 6.03), which showed continued improvement with additional DARA vs the 53.3% and 18.1% rates observed at the primary analysis, Kastritis reported.
Time to hematologic CR was 67.5 days and 85.0 days in the treatment groups, respectively, and median duration of hematologic CR was not reached in either group.
A significant 56% improvement was also observed in MOD-PFS (hazard ratio [HR], 0.44). Median MOD-PFS was not reached in the D-VCd group and was 30.3 months in the VCd group.
A significant 38% improvement was observed in OS (HR, 0.62), 5-year OS was 76.1% vs 64.7% in the D-VCd and VCd groups, respectively, he said.
“[The OS] benefit occurred even though more than 70% of the patients in the VCd arm who received a subsequent therapy were treated with a DARA-based regimen,” he stressed. “This further emphasizes the importance of using DSTS in the frontline setting.”
Trial participants had newly diagnosed AL amyloidosis with measurable hematologic disease, one or more involved organs, cardiac stage I-IIIA, estimated glomerular filtration rate of at least 20 mL/min, and absence of symptomatic multiple myeloma. They were randomized 1:1 to the two treatment groups. All patients received 1.3 mg/m2 of bortezomib by weekly injection, 300 mg/m2 of cyclophosphamide either by weekly oral or intravenous administration, and 20-40 mg of dexamethasone by weekly oral or intravenous administration for six 28-day cycles.
Those in the D-VCd group also received 1800 mg of DARA coformulated with rHuPH20 as a weekly injection in cycles 1-2, as a biweekly injection in cycles 3-6, and by injection every 4 weeks thereafter for up to 24 28-day cycles.
The median duration of treatment was 21.3 months for D-VCd and 5.3 months for VCd, and of 122 patients who received subsequent therapy, 82 (67%) received subsequent DARA.
Patients who achieved hematologic CR had better MOD-PFS and OS (HR, 0.30 and 0.41, respectively), regardless of the treatment received, he noted, adding that “this further supports that complete hematologic response is a valid early endpoint for the evaluation of anti-monoclonal therapies in AL amyloidosis.”
“I think this is very important for the further development of new treatments in this disease,” he said.
Of note, cardiac and renal response rates in the D-VCd group were about two to three times greater than those in the VCd group at 6, 12, 24, 36, and 48 months, Kastritis said.
Among 235 patients with an evaluable cardiac response, 113 achieved a very good partial response or better, including 76 of 118 (64.4%) in the D-VCd group and 37 of 117 (31.6%) in the VCd group. Of these, 48 (40.7%) and 16 (13.7%) achieved a cardiac CR.
Grade 3 or 4 treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients in the D-VCd and VCd groups, respectively, were lymphopenia (13% and 10%), pneumonia (8% and 4%), hypokalemia (2% and 5%), and peripheral edema (3% and 6%), he noted, adding that systemic administration-related reactions occurred in 14 (7%) of patients receiving D-VCd; all were grade 1 or 2 and most (86%) occurred after the first injection. TEAEs led to treatment discontinuation in 5% and 4% of patients in the groups, respectively.
No new safety signals were observed during the extended follow-up, he said.
Kastritis reported relationships with Pfizer, Genesis Pharma, Sanofi, AbbVie, GSK, Prothena, Janssen, and Amgen.
A version of this article first appeared on Medscape.com.
Adding DARA to VCd (D-VCd; Darzalex Faspro; Janssen Biotech) provided deeper and more rapid hematologic response and clinically meaningful and statistically significant improvement in overall survival (OS) and major organ deterioration progression-free survival (MOD-PFS), combined with 40.7% cardiac complete response (CR), first author Efstathios Kastritis, MD, said during presentation of an oral abstract at the American Society of Hematology (ASH) 2024 Annual Meeting.
“The Andromeda study is the first comparing two contemporary regimens that shows a significant survival improvement for patients with AL amyloidosis,” said Kastritis, an associate professor at the National and Kapodistrian University of Athens in Greece. “These findings reaffirm frontline D-VCd as the standard of care in this difficult-to-treat disease.”
The regimen was approved for this indication in 2021 based on prior earlier findings from the Andromeda trial. The current results are from a preplanned analysis for MOD-PFS and OS.
At a median follow-up of 61.4 months, the overall hematologic CR rates were 59.5% and 19.2% among 388 patients randomized to receive D-VCd or VCd, respectively (odds ratio, 6.03), which showed continued improvement with additional DARA vs the 53.3% and 18.1% rates observed at the primary analysis, Kastritis reported.
Time to hematologic CR was 67.5 days and 85.0 days in the treatment groups, respectively, and median duration of hematologic CR was not reached in either group.
A significant 56% improvement was also observed in MOD-PFS (hazard ratio [HR], 0.44). Median MOD-PFS was not reached in the D-VCd group and was 30.3 months in the VCd group.
A significant 38% improvement was observed in OS (HR, 0.62), 5-year OS was 76.1% vs 64.7% in the D-VCd and VCd groups, respectively, he said.
“[The OS] benefit occurred even though more than 70% of the patients in the VCd arm who received a subsequent therapy were treated with a DARA-based regimen,” he stressed. “This further emphasizes the importance of using DSTS in the frontline setting.”
Trial participants had newly diagnosed AL amyloidosis with measurable hematologic disease, one or more involved organs, cardiac stage I-IIIA, estimated glomerular filtration rate of at least 20 mL/min, and absence of symptomatic multiple myeloma. They were randomized 1:1 to the two treatment groups. All patients received 1.3 mg/m2 of bortezomib by weekly injection, 300 mg/m2 of cyclophosphamide either by weekly oral or intravenous administration, and 20-40 mg of dexamethasone by weekly oral or intravenous administration for six 28-day cycles.
Those in the D-VCd group also received 1800 mg of DARA coformulated with rHuPH20 as a weekly injection in cycles 1-2, as a biweekly injection in cycles 3-6, and by injection every 4 weeks thereafter for up to 24 28-day cycles.
The median duration of treatment was 21.3 months for D-VCd and 5.3 months for VCd, and of 122 patients who received subsequent therapy, 82 (67%) received subsequent DARA.
Patients who achieved hematologic CR had better MOD-PFS and OS (HR, 0.30 and 0.41, respectively), regardless of the treatment received, he noted, adding that “this further supports that complete hematologic response is a valid early endpoint for the evaluation of anti-monoclonal therapies in AL amyloidosis.”
“I think this is very important for the further development of new treatments in this disease,” he said.
Of note, cardiac and renal response rates in the D-VCd group were about two to three times greater than those in the VCd group at 6, 12, 24, 36, and 48 months, Kastritis said.
Among 235 patients with an evaluable cardiac response, 113 achieved a very good partial response or better, including 76 of 118 (64.4%) in the D-VCd group and 37 of 117 (31.6%) in the VCd group. Of these, 48 (40.7%) and 16 (13.7%) achieved a cardiac CR.
Grade 3 or 4 treatment-emergent adverse events (TEAEs) occurring in at least 5% of patients in the D-VCd and VCd groups, respectively, were lymphopenia (13% and 10%), pneumonia (8% and 4%), hypokalemia (2% and 5%), and peripheral edema (3% and 6%), he noted, adding that systemic administration-related reactions occurred in 14 (7%) of patients receiving D-VCd; all were grade 1 or 2 and most (86%) occurred after the first injection. TEAEs led to treatment discontinuation in 5% and 4% of patients in the groups, respectively.
No new safety signals were observed during the extended follow-up, he said.
Kastritis reported relationships with Pfizer, Genesis Pharma, Sanofi, AbbVie, GSK, Prothena, Janssen, and Amgen.
A version of this article first appeared on Medscape.com.
FROM ASH 2024
FDA Approves Cosibelimab for Cutaneous SCC
The programmed death ligand-1 (PD-L1)–blocking antibody is the first and only treatment of its kind approved for advanced CSCC, according to a Checkpoint Therapeutics press release. The FDA approval was based on findings from the multicenter, open-label Study CK-301-101 trial of 109 patients.
In that trial, the objective response rate (ORR) was 47% in 78 patients with metastatic CSCC and 48% in 31 patients with locally advanced CSCC. Median duration of response (DOR) in treated patients was not reached in those with metastatic disease and was 17.7 months in those with locally advanced disease, according to the FDA approval notice.
Adverse reactions occurring in at least 10% of patients included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The recommended treatment dose, according to the prescribing information, is 1200 mg given as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
The agent offers “a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response,” Checkpoint Therapeutics president and chief executive officer James Oliviero stated in the company press release.
The agent has also “demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity, another potential differentiating feature of the drug compared to existing marketing therapies for CSCC,” Oliviero noted.
“CSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis,” stated Emily Ruiz, MD, academic director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital and director of the High-Risk Skin Cancer Clinic at Dana-Farber Brigham Cancer Center.
“With its dual mechanisms of action and compelling safety profile, this promising drug will provide US oncologists with an important new immunotherapy option for the treatment of CSCC,” she added.
A version of this article appeared on Medscape.com.
The programmed death ligand-1 (PD-L1)–blocking antibody is the first and only treatment of its kind approved for advanced CSCC, according to a Checkpoint Therapeutics press release. The FDA approval was based on findings from the multicenter, open-label Study CK-301-101 trial of 109 patients.
In that trial, the objective response rate (ORR) was 47% in 78 patients with metastatic CSCC and 48% in 31 patients with locally advanced CSCC. Median duration of response (DOR) in treated patients was not reached in those with metastatic disease and was 17.7 months in those with locally advanced disease, according to the FDA approval notice.
Adverse reactions occurring in at least 10% of patients included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The recommended treatment dose, according to the prescribing information, is 1200 mg given as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
The agent offers “a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response,” Checkpoint Therapeutics president and chief executive officer James Oliviero stated in the company press release.
The agent has also “demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity, another potential differentiating feature of the drug compared to existing marketing therapies for CSCC,” Oliviero noted.
“CSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis,” stated Emily Ruiz, MD, academic director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital and director of the High-Risk Skin Cancer Clinic at Dana-Farber Brigham Cancer Center.
“With its dual mechanisms of action and compelling safety profile, this promising drug will provide US oncologists with an important new immunotherapy option for the treatment of CSCC,” she added.
A version of this article appeared on Medscape.com.
The programmed death ligand-1 (PD-L1)–blocking antibody is the first and only treatment of its kind approved for advanced CSCC, according to a Checkpoint Therapeutics press release. The FDA approval was based on findings from the multicenter, open-label Study CK-301-101 trial of 109 patients.
In that trial, the objective response rate (ORR) was 47% in 78 patients with metastatic CSCC and 48% in 31 patients with locally advanced CSCC. Median duration of response (DOR) in treated patients was not reached in those with metastatic disease and was 17.7 months in those with locally advanced disease, according to the FDA approval notice.
Adverse reactions occurring in at least 10% of patients included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
The recommended treatment dose, according to the prescribing information, is 1200 mg given as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
The agent offers “a differentiated treatment option versus available therapies by binding to PD-L1, rather than programmed death receptor-1 (PD-1), to release the inhibitory effects of PD-L1 on the anti-tumor immune response,” Checkpoint Therapeutics president and chief executive officer James Oliviero stated in the company press release.
The agent has also “demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity, another potential differentiating feature of the drug compared to existing marketing therapies for CSCC,” Oliviero noted.
“CSCC is the second most common form of skin cancer, and those diagnosed with advanced disease that has recurred or metastasized face a poor prognosis,” stated Emily Ruiz, MD, academic director of the Mohs and Dermatologic Surgery Center at Brigham and Women’s Hospital and director of the High-Risk Skin Cancer Clinic at Dana-Farber Brigham Cancer Center.
“With its dual mechanisms of action and compelling safety profile, this promising drug will provide US oncologists with an important new immunotherapy option for the treatment of CSCC,” she added.
A version of this article appeared on Medscape.com.
Vertebral Fractures and Myeloma: Link Is Questionable
The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.
“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview.
To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.
During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.
“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.
The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.
A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.
Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said.
Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.
“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.
Rønnemoes reported no disclosures.
A version of this article first appeared on Medscape.com.
The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.
“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview.
To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.
During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.
“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.
The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.
A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.
Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said.
Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.
“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.
Rønnemoes reported no disclosures.
A version of this article first appeared on Medscape.com.
The findings suggest that evaluation for underlying MM — as recommended in some clinical guidelines — may be unwarranted in the absence of symptoms or other clinical findings leading to suspicion of underlying MM, Rasmus Rønnemoes, MD, reported during a poster session at the annual American Society of Hematology conference.
“Some guidelines say to evaluate patients with vertebral fractures, including measuring serum M-protein and free light chains, and others say to evaluate only if there is an indication — but without specifying what an indication is,” Rønnemoes, of the Danish Red Blood Cell Center, Copenhagen University Hospital — Rigshospitalet, Denmark, said in an interview.
To assess the association between vertebral fractures and MM, he and his colleagues studied 9065 individuals from the Danish general population, aged 33-94 years (median, 62 years) who were part of the Copenhagen General Population Study and who had attended a health examination and underwent a CT scan as part of the study. Overall, 1574 (17.4%) had one or more incidentally discovered vertebral fracture on the CT scan, and of those, 875 (9.7%) had a grade 1 fracture as the highest grade and 699 (7.7%) had grade 2-3 fractures.
During a median prospective follow-up of 5.5 years after the scan, 13 were diagnosed with myeloma.
“We did find an increased relative risk of myeloma in these patients, which we thought was quite interesting, but the absolute risk was quite modest,” Rønnemoes said.
The absolute 5-year risk for MM was 0.07% and 0.10% in women and men without vertebral fractures, respectively, and the risk for those with fractures was 0.17% and 0.24% in women and men with grade 1 fractures, respectively, and 0.43% and 0.63% in women and men with grade 2-3 fractures, respectively.
A case-cohort study based on more than 56,000 individuals from the UK Biobank cohort who had undergone a dual-energy x-ray absorptiometry scan as part of that study validated the findings in the Danish population: At median follow-up of 4 years, 49 patients in the validation cohort were diagnosed with myeloma, and the absolute 5-year risk for myeloma was 0.06% and 0.12% in women and men with grade 1 fractures, respectively, and 0.14% and 0.26% in women and men with grade 2-3 fractures, respectively.
Given the apparently modest absolute risk for MM in patients with incidentally discovered fractures in the absence of strong indications or risk, treatment guidelines should consider the potential harms associated with additional work up and a monoclonal gammopathy of undetermined significance diagnosis, Rønnemoes said.
Such a diagnosis can lead to psychological distress in individuals who may never develop malignant disease, he noted.
“We just hope to bring more value to the guidelines by identifying who should be evaluated,” he said, adding that additional study — perhaps looking more closely at whether only the more severe fractures should prompt additional evaluation — is warranted.
Rønnemoes reported no disclosures.
A version of this article first appeared on Medscape.com.
FROM ASH 2024
Epcore NHL-1 Update: Treatment Effective Before CAR T
These findings show that epcoritamab — a bispecific antibody therapy available off the shelf and shown in the overall R/R LBCL population in Epcore NHL-1 to be effective following CAR T–cell therapy — can also be administered safely and effectively before CAR T in patients with R/R LBCL.
This is of particular note for patients who may be ineligible for CAR T or whose access to CAR T is limited, first author Yasmin H. Karimi, MD, said in an interview during a poster presentation at the annual American Society of Hematology (ASH) conference.
With over 3 years of follow-up, epcoritamab monotherapy was associated with an overall response rate and complete response rate of 61% and 45%, respectively, in 96 CAR T-naive patients, and side effects were manageable, said Karimi, of the University of Michigan, Ann Arbor, Michigan.
In Epcore NHL-1, epcoritamab — a CD3xCD20 T-cell-engaging bispecific antibody — led to deep and durable responses with manageable toxicity in the patients with R/R LBCL including both CAR T–treated and CAR T–naive patients. The agent was subsequently approved for the treatment of adults with different types of R/R LBCL and follicular lymphoma after at least two prior lines of therapy. Among those who had received CAR T–cell therapy, the ORR/CR rates were 54% and 34%, according to results reported at ASH 2022.
Patients included in the trial were adults with R/R CD20 LBCL, including diffuse LBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma with at least two prior lines of systemic antilymphoma therapy. They were treated with two step-up doses of epcoritamab followed by 48-mg full doses in 28-day cycles, including weekly treatment for cycles 1-3, biweekly treatment for cycles 4-9, and treatment every 4 weeks for cycle 10 and any subsequent cycles, until disease progression or unacceptable toxicity.
In the current subgroup analysis of 96 CAR T–naive patients, median duration of response was 18.4 months, median duration of complete response was 28.6 months, and an estimated 46% of patients remained in complete response at 36 months, Karimi said.
Median progression-free survival duration was 4.3 months overall and 33.3 months among complete responders. Median overall survival was 15.4 months and was not reached in complete responders.
At 3 years, an estimated 40% of patients overall and 83% of complete responders had not initiated any other antilymphoma therapy, and of the 35 who received subsequent antilymphoma therapy, 10 (29%) received CAR T. Six of the 10 were alive at data cutoff, and 33 of 74 patients evaluable for minimal residual disease (MRD) were MRD-negative.
The most common treatment-emergent adverse events were cytokine release syndrome (CRS) in 60% of patients, diarrhea in 24%, pyrexia in 23%, fatigue in 22%, neutropenia in 22%, and injection-site reaction in 21%.
Fatal reactions occurred in 18 patients. Of these, nine were related to COVID-19 infection. CRS events were mostly of grade 1 or 2; 4% were of grade 3. CRS occurred most often following cycle 1 and resolved in all but two patients. ICANS occurred in seven patients, clinical tumor lysis syndrome occurred in two patients, and immunoglobulin G levels decreased by a median of about 20% after the story of treatment and remained stable over time, Karimi noted.
“These findings show that epcoritamab can be administered safely and effectively in CAR T–naive or CAR T–exposed patients with R/R LBCL,” she said.
Karimi reported relationships with AstraZeneca, Lily/Loxo, Merck, AbbVie, ADC Therapeutics, Xencor, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
These findings show that epcoritamab — a bispecific antibody therapy available off the shelf and shown in the overall R/R LBCL population in Epcore NHL-1 to be effective following CAR T–cell therapy — can also be administered safely and effectively before CAR T in patients with R/R LBCL.
This is of particular note for patients who may be ineligible for CAR T or whose access to CAR T is limited, first author Yasmin H. Karimi, MD, said in an interview during a poster presentation at the annual American Society of Hematology (ASH) conference.
With over 3 years of follow-up, epcoritamab monotherapy was associated with an overall response rate and complete response rate of 61% and 45%, respectively, in 96 CAR T-naive patients, and side effects were manageable, said Karimi, of the University of Michigan, Ann Arbor, Michigan.
In Epcore NHL-1, epcoritamab — a CD3xCD20 T-cell-engaging bispecific antibody — led to deep and durable responses with manageable toxicity in the patients with R/R LBCL including both CAR T–treated and CAR T–naive patients. The agent was subsequently approved for the treatment of adults with different types of R/R LBCL and follicular lymphoma after at least two prior lines of therapy. Among those who had received CAR T–cell therapy, the ORR/CR rates were 54% and 34%, according to results reported at ASH 2022.
Patients included in the trial were adults with R/R CD20 LBCL, including diffuse LBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma with at least two prior lines of systemic antilymphoma therapy. They were treated with two step-up doses of epcoritamab followed by 48-mg full doses in 28-day cycles, including weekly treatment for cycles 1-3, biweekly treatment for cycles 4-9, and treatment every 4 weeks for cycle 10 and any subsequent cycles, until disease progression or unacceptable toxicity.
In the current subgroup analysis of 96 CAR T–naive patients, median duration of response was 18.4 months, median duration of complete response was 28.6 months, and an estimated 46% of patients remained in complete response at 36 months, Karimi said.
Median progression-free survival duration was 4.3 months overall and 33.3 months among complete responders. Median overall survival was 15.4 months and was not reached in complete responders.
At 3 years, an estimated 40% of patients overall and 83% of complete responders had not initiated any other antilymphoma therapy, and of the 35 who received subsequent antilymphoma therapy, 10 (29%) received CAR T. Six of the 10 were alive at data cutoff, and 33 of 74 patients evaluable for minimal residual disease (MRD) were MRD-negative.
The most common treatment-emergent adverse events were cytokine release syndrome (CRS) in 60% of patients, diarrhea in 24%, pyrexia in 23%, fatigue in 22%, neutropenia in 22%, and injection-site reaction in 21%.
Fatal reactions occurred in 18 patients. Of these, nine were related to COVID-19 infection. CRS events were mostly of grade 1 or 2; 4% were of grade 3. CRS occurred most often following cycle 1 and resolved in all but two patients. ICANS occurred in seven patients, clinical tumor lysis syndrome occurred in two patients, and immunoglobulin G levels decreased by a median of about 20% after the story of treatment and remained stable over time, Karimi noted.
“These findings show that epcoritamab can be administered safely and effectively in CAR T–naive or CAR T–exposed patients with R/R LBCL,” she said.
Karimi reported relationships with AstraZeneca, Lily/Loxo, Merck, AbbVie, ADC Therapeutics, Xencor, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
These findings show that epcoritamab — a bispecific antibody therapy available off the shelf and shown in the overall R/R LBCL population in Epcore NHL-1 to be effective following CAR T–cell therapy — can also be administered safely and effectively before CAR T in patients with R/R LBCL.
This is of particular note for patients who may be ineligible for CAR T or whose access to CAR T is limited, first author Yasmin H. Karimi, MD, said in an interview during a poster presentation at the annual American Society of Hematology (ASH) conference.
With over 3 years of follow-up, epcoritamab monotherapy was associated with an overall response rate and complete response rate of 61% and 45%, respectively, in 96 CAR T-naive patients, and side effects were manageable, said Karimi, of the University of Michigan, Ann Arbor, Michigan.
In Epcore NHL-1, epcoritamab — a CD3xCD20 T-cell-engaging bispecific antibody — led to deep and durable responses with manageable toxicity in the patients with R/R LBCL including both CAR T–treated and CAR T–naive patients. The agent was subsequently approved for the treatment of adults with different types of R/R LBCL and follicular lymphoma after at least two prior lines of therapy. Among those who had received CAR T–cell therapy, the ORR/CR rates were 54% and 34%, according to results reported at ASH 2022.
Patients included in the trial were adults with R/R CD20 LBCL, including diffuse LBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma with at least two prior lines of systemic antilymphoma therapy. They were treated with two step-up doses of epcoritamab followed by 48-mg full doses in 28-day cycles, including weekly treatment for cycles 1-3, biweekly treatment for cycles 4-9, and treatment every 4 weeks for cycle 10 and any subsequent cycles, until disease progression or unacceptable toxicity.
In the current subgroup analysis of 96 CAR T–naive patients, median duration of response was 18.4 months, median duration of complete response was 28.6 months, and an estimated 46% of patients remained in complete response at 36 months, Karimi said.
Median progression-free survival duration was 4.3 months overall and 33.3 months among complete responders. Median overall survival was 15.4 months and was not reached in complete responders.
At 3 years, an estimated 40% of patients overall and 83% of complete responders had not initiated any other antilymphoma therapy, and of the 35 who received subsequent antilymphoma therapy, 10 (29%) received CAR T. Six of the 10 were alive at data cutoff, and 33 of 74 patients evaluable for minimal residual disease (MRD) were MRD-negative.
The most common treatment-emergent adverse events were cytokine release syndrome (CRS) in 60% of patients, diarrhea in 24%, pyrexia in 23%, fatigue in 22%, neutropenia in 22%, and injection-site reaction in 21%.
Fatal reactions occurred in 18 patients. Of these, nine were related to COVID-19 infection. CRS events were mostly of grade 1 or 2; 4% were of grade 3. CRS occurred most often following cycle 1 and resolved in all but two patients. ICANS occurred in seven patients, clinical tumor lysis syndrome occurred in two patients, and immunoglobulin G levels decreased by a median of about 20% after the story of treatment and remained stable over time, Karimi noted.
“These findings show that epcoritamab can be administered safely and effectively in CAR T–naive or CAR T–exposed patients with R/R LBCL,” she said.
Karimi reported relationships with AstraZeneca, Lily/Loxo, Merck, AbbVie, ADC Therapeutics, Xencor, and Roche/Genentech.
A version of this article first appeared on Medscape.com.
FROM ASH 2024
FDA Approves Durvalumab for Limited-Stage SCLC
The Food and Drug Administration approval makes the monoclonal antibody — which is already approved for multiple tumor types — the first immunotherapy regimen approved in this setting, AstraZeneca noted in a press release.
“Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer,” international coordinating investigator on the trial, Suresh Senan, PhD, stated in the press release. “This finding represents the first advance for this disease in 4 decades.”
Approval, which followed Priority Review and Breakthrough Therapy Designation, was based on findings from the phase 3 ADRIATIC trial showing a 27% reduction in the risk for death with durvalumab vs placebo.
Findings from the trial were reported during a plenary session at the 2024 American Society of Clinical Oncology conference, and subsequently published in The New England Journal of Medicine.
In 730 patients with LS-SCLC who were randomized 1:1:1 to receive single-agent durvalumab, durvalumab in combination with tremelimumab, or placebo, overall survival (OS) and progression-free survival (PFS) were significantly improved with durvalumab alone vs placebo (hazard ratio, 0.73 and 0.76, for OS and PFS, respectively). Median OS was 55.9 months vs 33.4 months with durvalumab vs placebo, and PFS was 16.6 vs 9.2 months, respectively.
Senan, a professor of clinical experimental radiotherapy at the Amsterdam University Medical Center in the Netherlands, noted in the press release that 57% of patients were still alive at 3 years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting.
“This new treatment option is a game changer for patients with limited-stage small cell lung cancer, a disease known for its high rate of recurrence,” Dusty Donaldson, founder and executive director of the nonprofit advocacy organization LiveLung, stated in the release. “Historically, more often than not, clinical trials to identify new treatment options for this type of cancer have failed to show benefit. We are therefore so excited that many more people will now have the opportunity to access this immunotherapy treatment that holds the potential to significantly improve outcomes.”
Adverse reactions occurring in at least 20% of patients in the ADRIATIC trial included pneumonitis or radiation pneumonitis and fatigue.
The recommended durvalumab dose, according to prescribing information, is 1500 mg every 4 weeks for patients weighing at least 30 kg and 20 mg/kg every 4 weeks for those weighing less than 30 kg, until disease progression or unacceptable toxicity or a maximum of 24 months.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration approval makes the monoclonal antibody — which is already approved for multiple tumor types — the first immunotherapy regimen approved in this setting, AstraZeneca noted in a press release.
“Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer,” international coordinating investigator on the trial, Suresh Senan, PhD, stated in the press release. “This finding represents the first advance for this disease in 4 decades.”
Approval, which followed Priority Review and Breakthrough Therapy Designation, was based on findings from the phase 3 ADRIATIC trial showing a 27% reduction in the risk for death with durvalumab vs placebo.
Findings from the trial were reported during a plenary session at the 2024 American Society of Clinical Oncology conference, and subsequently published in The New England Journal of Medicine.
In 730 patients with LS-SCLC who were randomized 1:1:1 to receive single-agent durvalumab, durvalumab in combination with tremelimumab, or placebo, overall survival (OS) and progression-free survival (PFS) were significantly improved with durvalumab alone vs placebo (hazard ratio, 0.73 and 0.76, for OS and PFS, respectively). Median OS was 55.9 months vs 33.4 months with durvalumab vs placebo, and PFS was 16.6 vs 9.2 months, respectively.
Senan, a professor of clinical experimental radiotherapy at the Amsterdam University Medical Center in the Netherlands, noted in the press release that 57% of patients were still alive at 3 years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting.
“This new treatment option is a game changer for patients with limited-stage small cell lung cancer, a disease known for its high rate of recurrence,” Dusty Donaldson, founder and executive director of the nonprofit advocacy organization LiveLung, stated in the release. “Historically, more often than not, clinical trials to identify new treatment options for this type of cancer have failed to show benefit. We are therefore so excited that many more people will now have the opportunity to access this immunotherapy treatment that holds the potential to significantly improve outcomes.”
Adverse reactions occurring in at least 20% of patients in the ADRIATIC trial included pneumonitis or radiation pneumonitis and fatigue.
The recommended durvalumab dose, according to prescribing information, is 1500 mg every 4 weeks for patients weighing at least 30 kg and 20 mg/kg every 4 weeks for those weighing less than 30 kg, until disease progression or unacceptable toxicity or a maximum of 24 months.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration approval makes the monoclonal antibody — which is already approved for multiple tumor types — the first immunotherapy regimen approved in this setting, AstraZeneca noted in a press release.
“Durvalumab is the first and only systemic treatment following curative-intent, platinum-based chemoradiotherapy to show improved survival for patients with this aggressive form of lung cancer,” international coordinating investigator on the trial, Suresh Senan, PhD, stated in the press release. “This finding represents the first advance for this disease in 4 decades.”
Approval, which followed Priority Review and Breakthrough Therapy Designation, was based on findings from the phase 3 ADRIATIC trial showing a 27% reduction in the risk for death with durvalumab vs placebo.
Findings from the trial were reported during a plenary session at the 2024 American Society of Clinical Oncology conference, and subsequently published in The New England Journal of Medicine.
In 730 patients with LS-SCLC who were randomized 1:1:1 to receive single-agent durvalumab, durvalumab in combination with tremelimumab, or placebo, overall survival (OS) and progression-free survival (PFS) were significantly improved with durvalumab alone vs placebo (hazard ratio, 0.73 and 0.76, for OS and PFS, respectively). Median OS was 55.9 months vs 33.4 months with durvalumab vs placebo, and PFS was 16.6 vs 9.2 months, respectively.
Senan, a professor of clinical experimental radiotherapy at the Amsterdam University Medical Center in the Netherlands, noted in the press release that 57% of patients were still alive at 3 years after being treated with durvalumab, which underscores the practice-changing potential of this medicine in this setting.
“This new treatment option is a game changer for patients with limited-stage small cell lung cancer, a disease known for its high rate of recurrence,” Dusty Donaldson, founder and executive director of the nonprofit advocacy organization LiveLung, stated in the release. “Historically, more often than not, clinical trials to identify new treatment options for this type of cancer have failed to show benefit. We are therefore so excited that many more people will now have the opportunity to access this immunotherapy treatment that holds the potential to significantly improve outcomes.”
Adverse reactions occurring in at least 20% of patients in the ADRIATIC trial included pneumonitis or radiation pneumonitis and fatigue.
The recommended durvalumab dose, according to prescribing information, is 1500 mg every 4 weeks for patients weighing at least 30 kg and 20 mg/kg every 4 weeks for those weighing less than 30 kg, until disease progression or unacceptable toxicity or a maximum of 24 months.
A version of this article first appeared on Medscape.com.