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SU2C announces researcher-industry collaboration on immunotherapy
Stand Up To Cancer is calling for proposals to investigate additional uses for nivolumab, ipilimumab, elotuzumab, and urelumab, as part of a new researcher-industry collaborative program.
As many as four projects will be funded by Bristol-Myers Squibb, maker of the four agents, in the range of $1 million to $3 million each, according to a written statement from the American Association for Cancer Research (AACR).
The company will provide access to the three drugs already approved for the treatement of various cancers –nivolumab, ipilimumab, and elotuzumab– and to urelumab, an investigational agent that is currently in early clinical trials.
Proposals can include the study of one or more of the products, alone or in combination with other treatments, and may include products from other companies, as well as explore potential new uses for the drug(s), AACR said in the statement.
Nivolumab (Opdivo) is currently approved to treat advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma; Ipilimumab (Yervoy) is approved to treat melanoma; and elotuzumab (Empliciti) is approved to treat multiple myeloma, in conjunction with other drugs. Urelumab is being evaluated as a treatment for a range of cancers, including some hematological cancers, advanced colorectal cancer, and head and neck cancers.
The Stand Up To Cancer (SU2C) Catalyst program was launched in April to “use funding and materials from the pharmaceutical, biotechnology, diagnostic, and medical devices industries to accelerate research on cancer prevention, detection, and treatment,” according to a written statement from SU2C. Founding collaborators in addition to Bristol-Myers Squibb include Merck and Genentech.
The Catalyst projects must follow the SU2C model be carried out by a collaborative team, and be designed to accelerate the clinical use of therapeutic agents within the 3-year term of the grant, and to deliver near-term patient benefit.
The Request for Proposal for the Bristol-Myers Squibb agents is available at proposalCENTRAL, with proposals due by noon ET Monday, Aug. 15.
On Twitter @NikolaidesLaura
Stand Up To Cancer is calling for proposals to investigate additional uses for nivolumab, ipilimumab, elotuzumab, and urelumab, as part of a new researcher-industry collaborative program.
As many as four projects will be funded by Bristol-Myers Squibb, maker of the four agents, in the range of $1 million to $3 million each, according to a written statement from the American Association for Cancer Research (AACR).
The company will provide access to the three drugs already approved for the treatement of various cancers –nivolumab, ipilimumab, and elotuzumab– and to urelumab, an investigational agent that is currently in early clinical trials.
Proposals can include the study of one or more of the products, alone or in combination with other treatments, and may include products from other companies, as well as explore potential new uses for the drug(s), AACR said in the statement.
Nivolumab (Opdivo) is currently approved to treat advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma; Ipilimumab (Yervoy) is approved to treat melanoma; and elotuzumab (Empliciti) is approved to treat multiple myeloma, in conjunction with other drugs. Urelumab is being evaluated as a treatment for a range of cancers, including some hematological cancers, advanced colorectal cancer, and head and neck cancers.
The Stand Up To Cancer (SU2C) Catalyst program was launched in April to “use funding and materials from the pharmaceutical, biotechnology, diagnostic, and medical devices industries to accelerate research on cancer prevention, detection, and treatment,” according to a written statement from SU2C. Founding collaborators in addition to Bristol-Myers Squibb include Merck and Genentech.
The Catalyst projects must follow the SU2C model be carried out by a collaborative team, and be designed to accelerate the clinical use of therapeutic agents within the 3-year term of the grant, and to deliver near-term patient benefit.
The Request for Proposal for the Bristol-Myers Squibb agents is available at proposalCENTRAL, with proposals due by noon ET Monday, Aug. 15.
On Twitter @NikolaidesLaura
Stand Up To Cancer is calling for proposals to investigate additional uses for nivolumab, ipilimumab, elotuzumab, and urelumab, as part of a new researcher-industry collaborative program.
As many as four projects will be funded by Bristol-Myers Squibb, maker of the four agents, in the range of $1 million to $3 million each, according to a written statement from the American Association for Cancer Research (AACR).
The company will provide access to the three drugs already approved for the treatement of various cancers –nivolumab, ipilimumab, and elotuzumab– and to urelumab, an investigational agent that is currently in early clinical trials.
Proposals can include the study of one or more of the products, alone or in combination with other treatments, and may include products from other companies, as well as explore potential new uses for the drug(s), AACR said in the statement.
Nivolumab (Opdivo) is currently approved to treat advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma; Ipilimumab (Yervoy) is approved to treat melanoma; and elotuzumab (Empliciti) is approved to treat multiple myeloma, in conjunction with other drugs. Urelumab is being evaluated as a treatment for a range of cancers, including some hematological cancers, advanced colorectal cancer, and head and neck cancers.
The Stand Up To Cancer (SU2C) Catalyst program was launched in April to “use funding and materials from the pharmaceutical, biotechnology, diagnostic, and medical devices industries to accelerate research on cancer prevention, detection, and treatment,” according to a written statement from SU2C. Founding collaborators in addition to Bristol-Myers Squibb include Merck and Genentech.
The Catalyst projects must follow the SU2C model be carried out by a collaborative team, and be designed to accelerate the clinical use of therapeutic agents within the 3-year term of the grant, and to deliver near-term patient benefit.
The Request for Proposal for the Bristol-Myers Squibb agents is available at proposalCENTRAL, with proposals due by noon ET Monday, Aug. 15.
On Twitter @NikolaidesLaura
VIDEO: Dr. William A. Gradishar and Dr. Hope S. Rugo discuss #ASCO16
CHICAGO – Do anthracyclines still have a role in treating breast cancer? What are the implications for resistance of extending adjuvant aromatase inhibitors to 10 years or beyond? How best to treat women with metastatic hormone receptor–positive breast cancer, in light of findings on CDK 4/6 and mTOR inhibitors? Does sequence matter? In the case of HER2-positive disease, can a trastuzumab biosimilar be as effective as trastuzumab? And does a regimen with TDM-1 do more than reduce toxicity?
Dr. William A. Gradishar and Dr. Hope S. Rugo reflect on these questions and more in a video roundtable at the annual meeting of the American Society of Clinical Oncology.
Dr. William A. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago. He had no disclosures to report. Dr. Hope S. Rugo is professor of medicine at the University of California, San Francisco. She disclosed she is on the Speakers’ Bureau for Genomic Health and receives research funding (institutional) from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Lilly, GlaxoSmithKline, Genentech, Celsion, Nektar, and Merck.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
CHICAGO – Do anthracyclines still have a role in treating breast cancer? What are the implications for resistance of extending adjuvant aromatase inhibitors to 10 years or beyond? How best to treat women with metastatic hormone receptor–positive breast cancer, in light of findings on CDK 4/6 and mTOR inhibitors? Does sequence matter? In the case of HER2-positive disease, can a trastuzumab biosimilar be as effective as trastuzumab? And does a regimen with TDM-1 do more than reduce toxicity?
Dr. William A. Gradishar and Dr. Hope S. Rugo reflect on these questions and more in a video roundtable at the annual meeting of the American Society of Clinical Oncology.
Dr. William A. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago. He had no disclosures to report. Dr. Hope S. Rugo is professor of medicine at the University of California, San Francisco. She disclosed she is on the Speakers’ Bureau for Genomic Health and receives research funding (institutional) from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Lilly, GlaxoSmithKline, Genentech, Celsion, Nektar, and Merck.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
CHICAGO – Do anthracyclines still have a role in treating breast cancer? What are the implications for resistance of extending adjuvant aromatase inhibitors to 10 years or beyond? How best to treat women with metastatic hormone receptor–positive breast cancer, in light of findings on CDK 4/6 and mTOR inhibitors? Does sequence matter? In the case of HER2-positive disease, can a trastuzumab biosimilar be as effective as trastuzumab? And does a regimen with TDM-1 do more than reduce toxicity?
Dr. William A. Gradishar and Dr. Hope S. Rugo reflect on these questions and more in a video roundtable at the annual meeting of the American Society of Clinical Oncology.
Dr. William A. Gradishar is the Betsy Bramsen Professor of Breast Oncology at Northwestern University, Chicago. He had no disclosures to report. Dr. Hope S. Rugo is professor of medicine at the University of California, San Francisco. She disclosed she is on the Speakers’ Bureau for Genomic Health and receives research funding (institutional) from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Lilly, GlaxoSmithKline, Genentech, Celsion, Nektar, and Merck.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
EXPERT ANALYSIS FROM THE 2016 ASCO ANNUAL MEETING
VIDEO: Dr. Roy Herbst talks combinations, evolutions, and innovations in lung cancer
CHICAGO – One of the main take-home messages in lung cancer this year is the efficacy and tolerability demonstrated in combining checkpoint inhibitors for small-cell lung cancer, Dr. Roy Herbst said in an interview at the annual meeting of the American Society of Clinical Oncology. Combining ipilimumab and nivolumab doubled the response rate in patients with progressive small-cell lung cancer, compared with those receiving only nivolumab.
“The evolution of immunotherapy studies continues to show that immunotherapies are here to stay,” Dr. Herbst said. The next step is to expand on how many respond to them. One possibility is to combine an antiangiogenesis agent with a checkpoint inhibitor to drive T cells into the tumor. Dr. Herbst discusses results he presented at the meeting showing safety and tolerability were achieved when combining pembrolizumab and ramucirumab in patients with non–small-cell lung cancer, and the response rate was close to 30%.
In the video interview, Dr. Herbst, professor and chief of medical oncology, Yale Comprehensive Cancer Center, New Haven, Conn., also discusses the evolution of EGFR and ALK inhibitors, a new antibody drug conjugate showing early promise in small cell lung cancer, and the future of liquid biopsies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
CHICAGO – One of the main take-home messages in lung cancer this year is the efficacy and tolerability demonstrated in combining checkpoint inhibitors for small-cell lung cancer, Dr. Roy Herbst said in an interview at the annual meeting of the American Society of Clinical Oncology. Combining ipilimumab and nivolumab doubled the response rate in patients with progressive small-cell lung cancer, compared with those receiving only nivolumab.
“The evolution of immunotherapy studies continues to show that immunotherapies are here to stay,” Dr. Herbst said. The next step is to expand on how many respond to them. One possibility is to combine an antiangiogenesis agent with a checkpoint inhibitor to drive T cells into the tumor. Dr. Herbst discusses results he presented at the meeting showing safety and tolerability were achieved when combining pembrolizumab and ramucirumab in patients with non–small-cell lung cancer, and the response rate was close to 30%.
In the video interview, Dr. Herbst, professor and chief of medical oncology, Yale Comprehensive Cancer Center, New Haven, Conn., also discusses the evolution of EGFR and ALK inhibitors, a new antibody drug conjugate showing early promise in small cell lung cancer, and the future of liquid biopsies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
CHICAGO – One of the main take-home messages in lung cancer this year is the efficacy and tolerability demonstrated in combining checkpoint inhibitors for small-cell lung cancer, Dr. Roy Herbst said in an interview at the annual meeting of the American Society of Clinical Oncology. Combining ipilimumab and nivolumab doubled the response rate in patients with progressive small-cell lung cancer, compared with those receiving only nivolumab.
“The evolution of immunotherapy studies continues to show that immunotherapies are here to stay,” Dr. Herbst said. The next step is to expand on how many respond to them. One possibility is to combine an antiangiogenesis agent with a checkpoint inhibitor to drive T cells into the tumor. Dr. Herbst discusses results he presented at the meeting showing safety and tolerability were achieved when combining pembrolizumab and ramucirumab in patients with non–small-cell lung cancer, and the response rate was close to 30%.
In the video interview, Dr. Herbst, professor and chief of medical oncology, Yale Comprehensive Cancer Center, New Haven, Conn., also discusses the evolution of EGFR and ALK inhibitors, a new antibody drug conjugate showing early promise in small cell lung cancer, and the future of liquid biopsies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @NikolaidesLaura
EXPERT ANALYSIS FROM THE 2016 ASCO ANNUAL MEETING
FDA grants accelerated approval to nivolumab for Hodgkin lymphoma
The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.
Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.
The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.
The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.
The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.
On Twitter @NikolaidesLaura
The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.
Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.
The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.
The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.
The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.
On Twitter @NikolaidesLaura
The Food and Drug Administration has granted accelerated approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin.
Approval was based on a 65% objective response rate in 95 patients treated with nivolumab following autologous HSCT and posttransplantation brentuximab vedotin. All patients in the single-arm, multicenter trial had relapsed or refractory cHL and were enrolled regardless of PD-L1 expression status. Patients received a median of 17 doses of nivolumab, the FDA said in a written statement.
The median time to response was 2.1 months (range, 0.7-5.7 months). The estimated median duration of response was 8.7 months.
The FDA also issued a warning for complications of allogeneic HSCT after nivolumab, reporting that transplant-related deaths have occurred. Health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions, they said.
The most common adverse reactions in a second single-arm study used to evaluate safety (n = 263) were upper respiratory tract infection, cough, pyrexia, and diarrhea. Other immune-mediated adverse reactions, occurring in 1%-5% of patients, included rash, pneumonitis, hepatitis, hyperthyroidism, and colitis. The most common serious adverse reactions, which were reported in 1%-3% of patients, were pneumonia, pleural effusion, pneumonitis, pyrexia, infusion-related reaction, and rash.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and has been previously approved to treat advanced renal cell carcinoma, lung cancer, and melanoma.
On Twitter @NikolaidesLaura
NCI: Use of dug wells in New England linked with risk of bladder cancer
Increased risk of bladder cancer in New England may be partly due to drinking water from private wells, particularly dug wells established during the first half of the 20th century, according to researchers from the National Cancer Institute. Bladder cancer mortality rates have been elevated in northern New England for at least 5 decades. Incidence rates in Maine, New Hampshire, and Vermont are about 20% higher than in the United States overall, researchers said in a press release.
To explore reasons for the elevated risk, NCI investigators and colleagues in New England compared well water consumption, smoking, occupation, ancestry, use of wood-burning stoves, and consumption of various foods for 1,213 people in New England who were newly diagnosed with bladder cancer, and 1,418 people without bladder cancer who were matched by geographic area.
The amount of arsenic ingested through drinking water was estimated based on current levels and historical information. Increasing cumulative exposure was associated with an increasing risk of bladder cancer. Among people who used private wells, people who drank the most water had twice the risk of those who drank the least. Highest risk was seen among those who drank water from dug wells established before 1960, when the use of arsenic-based pesticides was common.
“Arsenic is an established cause of bladder cancer, largely based on observations from earlier studies in highly exposed populations,” said Debra Silverman, Sc.D., chief of the Occupational and Environmental Epidemiology Branch of the NCI, Rockville, Md., and senior author on the study. “However, emerging evidence suggests that low to moderate levels of exposure may also increase risk,” she said in the press release.
“Although smoking and employment in high-risk occupations both showed their expected associations with bladder cancer risk in this population, they were similar to those found in other populations,” Dr. Silverman said. “This suggests that neither risk factor explains the excess occurrence of bladder cancer in northern New England.”
These study results indicate historical consumption of water from private wells, particularly dug wells in an era when arsenic-based pesticides were widely used, may have contributed to the excess rate in New England residents, Dr. Silverman and colleagues concluded.
The study was published in the Journal of the National Cancer Institute (2016;108[9]:djw099).
On Twitter @NikolaidesLaura
Increased risk of bladder cancer in New England may be partly due to drinking water from private wells, particularly dug wells established during the first half of the 20th century, according to researchers from the National Cancer Institute. Bladder cancer mortality rates have been elevated in northern New England for at least 5 decades. Incidence rates in Maine, New Hampshire, and Vermont are about 20% higher than in the United States overall, researchers said in a press release.
To explore reasons for the elevated risk, NCI investigators and colleagues in New England compared well water consumption, smoking, occupation, ancestry, use of wood-burning stoves, and consumption of various foods for 1,213 people in New England who were newly diagnosed with bladder cancer, and 1,418 people without bladder cancer who were matched by geographic area.
The amount of arsenic ingested through drinking water was estimated based on current levels and historical information. Increasing cumulative exposure was associated with an increasing risk of bladder cancer. Among people who used private wells, people who drank the most water had twice the risk of those who drank the least. Highest risk was seen among those who drank water from dug wells established before 1960, when the use of arsenic-based pesticides was common.
“Arsenic is an established cause of bladder cancer, largely based on observations from earlier studies in highly exposed populations,” said Debra Silverman, Sc.D., chief of the Occupational and Environmental Epidemiology Branch of the NCI, Rockville, Md., and senior author on the study. “However, emerging evidence suggests that low to moderate levels of exposure may also increase risk,” she said in the press release.
“Although smoking and employment in high-risk occupations both showed their expected associations with bladder cancer risk in this population, they were similar to those found in other populations,” Dr. Silverman said. “This suggests that neither risk factor explains the excess occurrence of bladder cancer in northern New England.”
These study results indicate historical consumption of water from private wells, particularly dug wells in an era when arsenic-based pesticides were widely used, may have contributed to the excess rate in New England residents, Dr. Silverman and colleagues concluded.
The study was published in the Journal of the National Cancer Institute (2016;108[9]:djw099).
On Twitter @NikolaidesLaura
Increased risk of bladder cancer in New England may be partly due to drinking water from private wells, particularly dug wells established during the first half of the 20th century, according to researchers from the National Cancer Institute. Bladder cancer mortality rates have been elevated in northern New England for at least 5 decades. Incidence rates in Maine, New Hampshire, and Vermont are about 20% higher than in the United States overall, researchers said in a press release.
To explore reasons for the elevated risk, NCI investigators and colleagues in New England compared well water consumption, smoking, occupation, ancestry, use of wood-burning stoves, and consumption of various foods for 1,213 people in New England who were newly diagnosed with bladder cancer, and 1,418 people without bladder cancer who were matched by geographic area.
The amount of arsenic ingested through drinking water was estimated based on current levels and historical information. Increasing cumulative exposure was associated with an increasing risk of bladder cancer. Among people who used private wells, people who drank the most water had twice the risk of those who drank the least. Highest risk was seen among those who drank water from dug wells established before 1960, when the use of arsenic-based pesticides was common.
“Arsenic is an established cause of bladder cancer, largely based on observations from earlier studies in highly exposed populations,” said Debra Silverman, Sc.D., chief of the Occupational and Environmental Epidemiology Branch of the NCI, Rockville, Md., and senior author on the study. “However, emerging evidence suggests that low to moderate levels of exposure may also increase risk,” she said in the press release.
“Although smoking and employment in high-risk occupations both showed their expected associations with bladder cancer risk in this population, they were similar to those found in other populations,” Dr. Silverman said. “This suggests that neither risk factor explains the excess occurrence of bladder cancer in northern New England.”
These study results indicate historical consumption of water from private wells, particularly dug wells in an era when arsenic-based pesticides were widely used, may have contributed to the excess rate in New England residents, Dr. Silverman and colleagues concluded.
The study was published in the Journal of the National Cancer Institute (2016;108[9]:djw099).
On Twitter @NikolaidesLaura
FDA approves fulvestrant for use in combination with palbociclib
The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
The Food and Drug Administration has expanded the indication for fulvestrant to include use in combination with palbociclib for the treatment of women with hormone receptor–positive (HR+), human epidermal growth factor receptor–2 negative (HER2–) advanced or metastatic breast cancer in women whose cancer has progressed after endocrine therapy.
The FDA first approved fulvestrant in 2002 as a monotherapy for the treatment of postmenopausal women with HR+ metastatic breast cancer that had progressed following endocrine therapy.
Expanded approval is based on data from the Phase III PALOMA-3 trial that found a 4.9 month improvement in progression-free survival with the combination of fulvestrant 500 mg and palbociclib 125 mg, compared with fulvestrant and placebo, in women with HR+ HER2– advanced breast cancer whose disease had progressed after endocrine therapy. Improvement in progression-free survival was seen irrespective of menopausal status, according to a press release from AstraZeneca, makers of fulvestrant.
The most common adverse reactions of any grade reported in PALOMA-3 of the combination vs. fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%), according to the press release.
Fulvestrant is marketed as Faslodex. The new label with prescribing information can be found on the FDA website.
Rate of BRCA testing up among young women with breast cancer
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
The rate at which young women diagnosed with breast cancer are undergoing genetic testing for BRCA1 and BRCA2 mutations has increased, investigators report online in JAMA Oncology.
In a study of 897 women aged 40 years and younger diagnosed with breast cancer at any one of 11 academic or community medical centers, 780 (87%) reported undergoing BRCA testing within the first year after diagnosis, reported Dr. Ann H. Partridge of the Dana-Farber Cancer Institute, Boston, and her associates (JAMA Onc. 2016 Feb 11. doi: 10.1001/jamaoncol.2015.5941).
Among the 780 women who had BRCA testing, 59 (7.6%) reported a BRCA1 mutation, 35 (4.5%) reported a BRCA2 mutation, and 35 (4.6%) reported an indeterminate result or variant of unknown clinical significance, the investigators said.
The frequency of testing increased over time. Of 39 women diagnosed with breast cancer in 2006, 30 (76.9%) elected to have testing, but by 2013, 123 (95.3%) of 129 women diagnosed with breast cancer reported BRCA testing.
The investigators attribute the increasing frequency of BRCA testing to the fact that most women in the group were insured, educated, and treated at cancer centers where comprehensive genetic counseling and testing services were widely available, but they also acknowledged the possibility that media attention to genetic breast cancer (in other words, the Angelina Jolie effect) may have motivated more women to bring up the issue of genetic risk with their physician or genetic counselor.
The study can be found online here.
On Twitter @NikolaidesLaura
FROM JAMA ONCOLOGY
FDA approves single-dose fosaprepitant for moderately emetogenic chemo
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved single-dose fosaprepitant for injection, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy.
Fosaprepitant for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.
Approval was based on a 78.9% complete response rate (no vomiting and no use of rescue therapy) during the delayed phase, 25-120 hours following initiation of moderately emetogenic chemotherapy, compared with a 68.5% complete response rate among those receiving the control regimen in a phase III trial (P less than .001). The treatment group of 502 patients received fosaprepitant for injection (150 mg) as a single intravenous infusion in combination with ondansetron and dexamethasone, compared with the control group of 498 patients who received ondansetron and dexamethasone alone, according to a statement released by Merck, developers of fosaprepitant (Emend).
The most-common adverse reactions reported among the patients receiving the fosaprepitant injection versus control regimen were fatigue (15% vs. 13%), diarrhea (13% vs. 11%), neutropenia (8% vs. 7%), asthenia (4% vs. 3%), anemia (3% vs. 2%), peripheral neuropathy (3% vs. 2%), leukopenia (2% vs. 1%), dyspepsia (2% vs. 1%), urinary tract infection (2% vs. 1%), and pain in extremity (2% vs. 1%), according to Merck.
On Twitter @NikolaidesLaura
FDA approves eribulin for advanced liposarcoma
The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.
Patients were randomized to receive either eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m2, 1,000 mg/m2, or 1,200 mg/m2 chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.
Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.
The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.
The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.
Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.
On Twitter @nikolaideslaura
The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.
Patients were randomized to receive either eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m2, 1,000 mg/m2, or 1,200 mg/m2 chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.
Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.
The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.
The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.
Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.
On Twitter @nikolaideslaura
The Food and Drug Administration has approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
The approval was based on improved overall survival (OS) in an open-label, randomized, multicenter trial of 446 patients with unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who had received at least two prior systemic chemotherapies (one of which must have included an anthracycline) and had experienced disease progression within 6 months of randomization, according to the Jan. 28 statement issued by the FDA.
Patients were randomized to receive either eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle or dacarbazine (at a dose of 850 mg/m2, 1,000 mg/m2, or 1,200 mg/m2 chosen by the investigator prior to randomization) on day 1 of a 21-day cycle.
Eribulin benefit was limited to the subgroup of patients with liposarcoma. The median OS was 15.6 vs. 8.4 months (HR 0.51 [95% CI: 0.35, 0.75]) and the median progression-free survival (PFS) was 2.9 vs. 1.7 months (HR 0.52 [95% CI: 0.35, 0.78]) in patients with liposarcoma treated with eribulin compared to dacarbazine, respectively. There was no evidence of efficacy for eribulin in patients with leiomyosarcoma.
The most common adverse reactions among those who received eribulin in the trial were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common grade 3-4 laboratory abnormalities were neutropenia, hypokalemia, and hypocalcemia.
The most common serious adverse reactions were neutropenia (4.9%) and pyrexia (4.5%). Febrile neutropenia occurred in 0.9% and fatal neutropenic sepsis in 0.9% of patients treated with eribulin. The most frequent adverse reactions leading to discontinuation were fatigue (0.9%) and thrombocytopenia (0.9%), according to the FDA statement.
Eribulin is marketed as Halaven injection by Eisai. The recommended dose and schedule for eribulin is 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.
On Twitter @nikolaideslaura
VIDEO: Dr. Hope S. Rugo discusses immunotherapy, neoadjuvant treatment highlights
SAN ANTONIO – Dr. Hope S. Rugo shared her insights on breast cancer research presented at the San Antonio Breast Cancer Symposium, focusing particularly on neoadjuvant treatments and immunotherapy.
“It’s exciting to think we may be able to treat patients with ER-positive and HER2-negative disease with a relatively limited course of a well-tolerated therapy,” Dr. Rugo said when discussing the results of a phase II trial evaluating neoadjuvant therapy with the antibody-drug conjugate trastuzumab emtansine (T-DM1).
Furthermore, results from another arm within the same trial may help to identify which patients with triple-negative breast cancer can get by with less chemotherapy, and potentially avoid anthracyclines, said Dr. Rugo, professor of medicine at the University of California, San Francisco, in a video interview.
She also untangled the perplexing results from two trials presented evaluating neoadjuvant carboplatin, and discussed the highlights of immunotherapy research presented at the symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Dr. Hope S. Rugo shared her insights on breast cancer research presented at the San Antonio Breast Cancer Symposium, focusing particularly on neoadjuvant treatments and immunotherapy.
“It’s exciting to think we may be able to treat patients with ER-positive and HER2-negative disease with a relatively limited course of a well-tolerated therapy,” Dr. Rugo said when discussing the results of a phase II trial evaluating neoadjuvant therapy with the antibody-drug conjugate trastuzumab emtansine (T-DM1).
Furthermore, results from another arm within the same trial may help to identify which patients with triple-negative breast cancer can get by with less chemotherapy, and potentially avoid anthracyclines, said Dr. Rugo, professor of medicine at the University of California, San Francisco, in a video interview.
She also untangled the perplexing results from two trials presented evaluating neoadjuvant carboplatin, and discussed the highlights of immunotherapy research presented at the symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN ANTONIO – Dr. Hope S. Rugo shared her insights on breast cancer research presented at the San Antonio Breast Cancer Symposium, focusing particularly on neoadjuvant treatments and immunotherapy.
“It’s exciting to think we may be able to treat patients with ER-positive and HER2-negative disease with a relatively limited course of a well-tolerated therapy,” Dr. Rugo said when discussing the results of a phase II trial evaluating neoadjuvant therapy with the antibody-drug conjugate trastuzumab emtansine (T-DM1).
Furthermore, results from another arm within the same trial may help to identify which patients with triple-negative breast cancer can get by with less chemotherapy, and potentially avoid anthracyclines, said Dr. Rugo, professor of medicine at the University of California, San Francisco, in a video interview.
She also untangled the perplexing results from two trials presented evaluating neoadjuvant carboplatin, and discussed the highlights of immunotherapy research presented at the symposium.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SABCS 2015
