ATLANTA – Within a cohort of children diagnosed with peanut allergy who were followed since 2001, peanut IgE levels increased significantly over time in all races, according to a preliminary analysis of data.

In an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology, lead study author Yasmin Hamzavi, MD, said that recent publications have implicated race as a factor in food sensitization, but how this may impact the management of food allergy has not been elucidated. “The novel aspect of this study is that we are not just looking at the baseline peanut IgE levels between the races, but at the rate of change in peanut IgE over time between the different races,” said Dr. Hamzavi, a fellow in the division of allergy and immunology at Northwell Health, Great Neck, N.Y. “My question was, does the level of peanut IgE decrease or increase faster in one race versus another?”

Doug Brunk/Frontline Medical News

A significant increase in peanut IgE over time was observed among all races (P less than .0002). In addition, white and Asian children showed an increasing trend in peanut IgE, while black children demonstrated a decreasing trend over time (P less than .099), a finding that Dr. Hamzavi described as “surprising and unusual.” She called for larger studies exploring factors for the noted increase among all races, such as changes in testing methods, food avoidance, and increasing sensitization. “Understanding the changes in peanut sensitization over time is a crucial step in determining the likelihood of clinical reactivity,” she said.

Dr. Hamzavi is reviewing data for a similar analysis of children with milk and egg allergy. She reported having no financial disclosures.

[email protected]

ATLANTA – Within a cohort of children diagnosed with peanut allergy who were followed since 2001, peanut IgE levels increased significantly over time in all races, according to a preliminary analysis of data.

In an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology, lead study author Yasmin Hamzavi, MD, said that recent publications have implicated race as a factor in food sensitization, but how this may impact the management of food allergy has not been elucidated. “The novel aspect of this study is that we are not just looking at the baseline peanut IgE levels between the races, but at the rate of change in peanut IgE over time between the different races,” said Dr. Hamzavi, a fellow in the division of allergy and immunology at Northwell Health, Great Neck, N.Y. “My question was, does the level of peanut IgE decrease or increase faster in one race versus another?”

Doug Brunk/Frontline Medical News

A significant increase in peanut IgE over time was observed among all races (P less than .0002). In addition, white and Asian children showed an increasing trend in peanut IgE, while black children demonstrated a decreasing trend over time (P less than .099), a finding that Dr. Hamzavi described as “surprising and unusual.” She called for larger studies exploring factors for the noted increase among all races, such as changes in testing methods, food avoidance, and increasing sensitization. “Understanding the changes in peanut sensitization over time is a crucial step in determining the likelihood of clinical reactivity,” she said.

Dr. Hamzavi is reviewing data for a similar analysis of children with milk and egg allergy. She reported having no financial disclosures.

[email protected]

ATLANTA – Within a cohort of children diagnosed with peanut allergy who were followed since 2001, peanut IgE levels increased significantly over time in all races, according to a preliminary analysis of data.

In an interview in advance of the annual meeting of the American Academy of Allergy, Asthma, and Immunology, lead study author Yasmin Hamzavi, MD, said that recent publications have implicated race as a factor in food sensitization, but how this may impact the management of food allergy has not been elucidated. “The novel aspect of this study is that we are not just looking at the baseline peanut IgE levels between the races, but at the rate of change in peanut IgE over time between the different races,” said Dr. Hamzavi, a fellow in the division of allergy and immunology at Northwell Health, Great Neck, N.Y. “My question was, does the level of peanut IgE decrease or increase faster in one race versus another?”

Doug Brunk/Frontline Medical News

A significant increase in peanut IgE over time was observed among all races (P less than .0002). In addition, white and Asian children showed an increasing trend in peanut IgE, while black children demonstrated a decreasing trend over time (P less than .099), a finding that Dr. Hamzavi described as “surprising and unusual.” She called for larger studies exploring factors for the noted increase among all races, such as changes in testing methods, food avoidance, and increasing sensitization. “Understanding the changes in peanut sensitization over time is a crucial step in determining the likelihood of clinical reactivity,” she said.

Dr. Hamzavi is reviewing data for a similar analysis of children with milk and egg allergy. She reported having no financial disclosures.

[email protected]

MIAMI BEACH – Growing evidence continues to point to a widening separation between female and male breast cancers, particularly with discoveries suggesting different pathways to disease and important genetic distinctions.

Therefore, the traditional practice of extrapolating findings from female breast cancer research to men with breast cancer no longer makes sense, Patrick I. Borgen, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

The incidence of male breast cancer is increasing. At the same time, fewer men with breast cancer get referred for and undergo genetic testing for their disease, said Dr. Borgen, chair of the department of surgery at Maimonides Medical Center in Brooklyn, N.Y.

Dr. Borgen explained in a video interview that both maternal and paternal inheritance of breast cancer are important, and they tie the lineage into a hypothesis for why BRCA mutations – which can predispose people to worse survival – have persisted through generations.

MIAMI BEACH – Growing evidence continues to point to a widening separation between female and male breast cancers, particularly with discoveries suggesting different pathways to disease and important genetic distinctions.

Therefore, the traditional practice of extrapolating findings from female breast cancer research to men with breast cancer no longer makes sense, Patrick I. Borgen, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

The incidence of male breast cancer is increasing. At the same time, fewer men with breast cancer get referred for and undergo genetic testing for their disease, said Dr. Borgen, chair of the department of surgery at Maimonides Medical Center in Brooklyn, N.Y.

Dr. Borgen explained in a video interview that both maternal and paternal inheritance of breast cancer are important, and they tie the lineage into a hypothesis for why BRCA mutations – which can predispose people to worse survival – have persisted through generations.

MIAMI BEACH – Growing evidence continues to point to a widening separation between female and male breast cancers, particularly with discoveries suggesting different pathways to disease and important genetic distinctions.

Therefore, the traditional practice of extrapolating findings from female breast cancer research to men with breast cancer no longer makes sense, Patrick I. Borgen, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

The incidence of male breast cancer is increasing. At the same time, fewer men with breast cancer get referred for and undergo genetic testing for their disease, said Dr. Borgen, chair of the department of surgery at Maimonides Medical Center in Brooklyn, N.Y.

Dr. Borgen explained in a video interview that both maternal and paternal inheritance of breast cancer are important, and they tie the lineage into a hypothesis for why BRCA mutations – which can predispose people to worse survival – have persisted through generations.

MIAMI BEACH – The remarkable progress seen with immune checkpoint inhibitors in metastatic melanoma, non–small-cell lung cancer, and other tumors has yet to be replicated in breast cancer, but it’s early days yet, and breast cancer researchers need more time before the ultimate clinical benefits of immunotherapy in breast cancer can be ascertained, said Adam M. Brufsky, MD, PhD, of the University of Pittsburgh.

Early studies with inhibitors of programmed death-1 (PD-1) and its ligand PD-L1 in patients with advanced triple-negative breast cancer have yielded only minimal response rates to date, but it it’s far too early to give up on the concept, Dr. Brufsky cautioned at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In a video interview, he discussed the challenges of treating breast cancers, which may be less immunogenic and have a lower tumor mutational burden than other malignancies that respond more readily to PD-1 inhibition. Several large, phase III clinical trials of checkpoint inhibitors combined with cytotoxic chemotherapy are underway, he said, and those eventual findings may shed light on the optimal approach to using immunotherapy to treat patients with refractory metastatic breast cancers.

MIAMI BEACH – The remarkable progress seen with immune checkpoint inhibitors in metastatic melanoma, non–small-cell lung cancer, and other tumors has yet to be replicated in breast cancer, but it’s early days yet, and breast cancer researchers need more time before the ultimate clinical benefits of immunotherapy in breast cancer can be ascertained, said Adam M. Brufsky, MD, PhD, of the University of Pittsburgh.

Early studies with inhibitors of programmed death-1 (PD-1) and its ligand PD-L1 in patients with advanced triple-negative breast cancer have yielded only minimal response rates to date, but it it’s far too early to give up on the concept, Dr. Brufsky cautioned at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In a video interview, he discussed the challenges of treating breast cancers, which may be less immunogenic and have a lower tumor mutational burden than other malignancies that respond more readily to PD-1 inhibition. Several large, phase III clinical trials of checkpoint inhibitors combined with cytotoxic chemotherapy are underway, he said, and those eventual findings may shed light on the optimal approach to using immunotherapy to treat patients with refractory metastatic breast cancers.

MIAMI BEACH – The remarkable progress seen with immune checkpoint inhibitors in metastatic melanoma, non–small-cell lung cancer, and other tumors has yet to be replicated in breast cancer, but it’s early days yet, and breast cancer researchers need more time before the ultimate clinical benefits of immunotherapy in breast cancer can be ascertained, said Adam M. Brufsky, MD, PhD, of the University of Pittsburgh.

Early studies with inhibitors of programmed death-1 (PD-1) and its ligand PD-L1 in patients with advanced triple-negative breast cancer have yielded only minimal response rates to date, but it it’s far too early to give up on the concept, Dr. Brufsky cautioned at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In a video interview, he discussed the challenges of treating breast cancers, which may be less immunogenic and have a lower tumor mutational burden than other malignancies that respond more readily to PD-1 inhibition. Several large, phase III clinical trials of checkpoint inhibitors combined with cytotoxic chemotherapy are underway, he said, and those eventual findings may shed light on the optimal approach to using immunotherapy to treat patients with refractory metastatic breast cancers.

MIAMI BEACH – Driven by efficacy demonstrated in ovarian cancer, a number of PARP inhibitors are in development and hold promise for treatment of breast cancer as well, including patients positive for the BRCA mutation.

Interestingly, early evidence suggests these agents could also treat BRCA-negative women, potentially expanding their future clinical utility, Kimberly L. Blackwell, MD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

MIAMI BEACH – Driven by efficacy demonstrated in ovarian cancer, a number of PARP inhibitors are in development and hold promise for treatment of breast cancer as well, including patients positive for the BRCA mutation.

Interestingly, early evidence suggests these agents could also treat BRCA-negative women, potentially expanding their future clinical utility, Kimberly L. Blackwell, MD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

MIAMI BEACH – Driven by efficacy demonstrated in ovarian cancer, a number of PARP inhibitors are in development and hold promise for treatment of breast cancer as well, including patients positive for the BRCA mutation.

Interestingly, early evidence suggests these agents could also treat BRCA-negative women, potentially expanding their future clinical utility, Kimberly L. Blackwell, MD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

NATIONAL HARBOR, MD. – Patients with early cervical cancer with negative sentinel lymph node biopsy who did not receive pelvic lymphadenectomy experienced less postsurgical morbidity than patients who underwent lymphadenectomy, with no drop in overall or recurrence-free survival, investigators report.

In SENTICOL2, a 30-center prospective randomized study that compared sentinel lymph node (SLN) biopsy alone with SLN biopsy plus pelvic lymph node dissection for patients with early cervical cancer, recurrence-free survival at 3 years was 92% for patients receiving SLN only, compared with 95% in patients who had pelvic node dissection.

Overall survival at 3 years was 98% for the SLN-only patients, compared with 99% for those who had pelvic node dissection. None of these differences were statistically significant, and there were no significant differences between the study arms’ non-censored progression-free and overall survival rates at 6 years, Patrice Mathevet, MD, reported at the annual meeting of the Society of Gynecologic Oncology.

The study’s primary objective, said Dr. Mathevet, professor of obstetrics and gynecology at the University of Lausanne, Switzerland, was to compare the surgical morbidity experienced in each study arm, including quality of life and lymphedema–related signs and symptoms. A secondary objective was to assess and compare both overall survival and the 3-year recurrence-free rate for each study arm.

Patients were included if they had cervical cancer at International Federation of Gynecology and Obstetrics stage IA, IB1, or IIA1, with no sign of regional or distant metastases. Pregnant patients were excluded.

SLN scintigraphy was performed using the combined technetium and patent blue dye method. Patients with no identified or unilateral SLNs were excluded from the study and underwent pelvic lymph node dissection, as were patients in whom SLN scintigraphy was not performed.

Once SLNs were identified for the remaining patients, any patients with SLN metastases found on frozen section were excluded as well, while patients with grossly non-suspicious nodes and those with negative nodes on frozen section were randomized to receive just SLN biopsy with or without hysterectomy, or to receive pelvic lymph node dissection with or without hysterectomy.

SLNs in both study arms were examined by 200 micrometer serial sectioning with immunohistochemistry. For the pelvic node dissection arm, the nodes were submitted for pathology examination according to the study institution’s standard of care.

Over a 40-month period from March 2009 to July 2012, 267 patients with early cervical cancer were recruited. In the end, 206 patients were included in the study and 61 patients with positive or absent SLN results became ineligible according to the protocol criteria.

Of the eligible patients, 105 were randomized to the SLN biopsy–only arm, while 101 were allocated to the SLN biopsy plus pelvic lymph node dissection arm. Taking both study arms together, the median number of SLNs taken was three per patient, with a median one node per side.

When Dr. Mathevet and his colleagues looked at pathology from the pelvic lymph node dissection arm, they found that there were no false negatives, meaning that all patients with negative SLNs also had negative pelvic nodes.

Patient quality of life as assessed by the Short Form Health Survey (SF-36) was significantly lower for patients who received pelvic lymph node dissection. Lower extremity lymphedema signs and symptoms were also more common in patients who had pelvic lymph node dissection, indicated by the larger mean mid-thigh circumference and more common patient-reported leg heaviness and leg fatigue in the pelvic node dissection group.

The lymphedema findings were encapsulated in a global lymphatic morbidity score of 33 for the SLN-only group, compared with 52 for the pelvic node dissection group (P = .0046).

“Sentinel lymph node biopsy may improve the management of early cervical cancer, as sentinel lymph node biopsy alone induced less surgical morbidity than full pelvic lymph node dissection,” said Dr. Mathevet.

Patients were followed for a mean of 51 months post-procedure, with a total of 16 patients lost to follow-up. Patients in the SLN-only arm had a total of 11 recurrences, of which 5 were metastatic, 4 were local, and 2 were pelvic nodal. One of the pelvic nodal recurrences led to the patient’s death.

In the patients receiving pelvic node dissection, there were four metastatic and two local recurrences, but the difference in recurrence rates between the two groups was not statistically significant.

“This study leads to the morbidity-sparing approach in cervical cancer treatment while omitting the full pelvic lymph node dissection if the sentinel lymph nodes are negative,” said Dr. Mathevet.

Dr. Mathevet reported no relevant conflicts of interest.

[email protected]

On Twitter @karioakes

NATIONAL HARBOR, MD. – Patients with early cervical cancer with negative sentinel lymph node biopsy who did not receive pelvic lymphadenectomy experienced less postsurgical morbidity than patients who underwent lymphadenectomy, with no drop in overall or recurrence-free survival, investigators report.

In SENTICOL2, a 30-center prospective randomized study that compared sentinel lymph node (SLN) biopsy alone with SLN biopsy plus pelvic lymph node dissection for patients with early cervical cancer, recurrence-free survival at 3 years was 92% for patients receiving SLN only, compared with 95% in patients who had pelvic node dissection.

Overall survival at 3 years was 98% for the SLN-only patients, compared with 99% for those who had pelvic node dissection. None of these differences were statistically significant, and there were no significant differences between the study arms’ non-censored progression-free and overall survival rates at 6 years, Patrice Mathevet, MD, reported at the annual meeting of the Society of Gynecologic Oncology.

The study’s primary objective, said Dr. Mathevet, professor of obstetrics and gynecology at the University of Lausanne, Switzerland, was to compare the surgical morbidity experienced in each study arm, including quality of life and lymphedema–related signs and symptoms. A secondary objective was to assess and compare both overall survival and the 3-year recurrence-free rate for each study arm.

Patients were included if they had cervical cancer at International Federation of Gynecology and Obstetrics stage IA, IB1, or IIA1, with no sign of regional or distant metastases. Pregnant patients were excluded.

SLN scintigraphy was performed using the combined technetium and patent blue dye method. Patients with no identified or unilateral SLNs were excluded from the study and underwent pelvic lymph node dissection, as were patients in whom SLN scintigraphy was not performed.

Once SLNs were identified for the remaining patients, any patients with SLN metastases found on frozen section were excluded as well, while patients with grossly non-suspicious nodes and those with negative nodes on frozen section were randomized to receive just SLN biopsy with or without hysterectomy, or to receive pelvic lymph node dissection with or without hysterectomy.

SLNs in both study arms were examined by 200 micrometer serial sectioning with immunohistochemistry. For the pelvic node dissection arm, the nodes were submitted for pathology examination according to the study institution’s standard of care.

Over a 40-month period from March 2009 to July 2012, 267 patients with early cervical cancer were recruited. In the end, 206 patients were included in the study and 61 patients with positive or absent SLN results became ineligible according to the protocol criteria.

Of the eligible patients, 105 were randomized to the SLN biopsy–only arm, while 101 were allocated to the SLN biopsy plus pelvic lymph node dissection arm. Taking both study arms together, the median number of SLNs taken was three per patient, with a median one node per side.

When Dr. Mathevet and his colleagues looked at pathology from the pelvic lymph node dissection arm, they found that there were no false negatives, meaning that all patients with negative SLNs also had negative pelvic nodes.

Patient quality of life as assessed by the Short Form Health Survey (SF-36) was significantly lower for patients who received pelvic lymph node dissection. Lower extremity lymphedema signs and symptoms were also more common in patients who had pelvic lymph node dissection, indicated by the larger mean mid-thigh circumference and more common patient-reported leg heaviness and leg fatigue in the pelvic node dissection group.

The lymphedema findings were encapsulated in a global lymphatic morbidity score of 33 for the SLN-only group, compared with 52 for the pelvic node dissection group (P = .0046).

“Sentinel lymph node biopsy may improve the management of early cervical cancer, as sentinel lymph node biopsy alone induced less surgical morbidity than full pelvic lymph node dissection,” said Dr. Mathevet.

Patients were followed for a mean of 51 months post-procedure, with a total of 16 patients lost to follow-up. Patients in the SLN-only arm had a total of 11 recurrences, of which 5 were metastatic, 4 were local, and 2 were pelvic nodal. One of the pelvic nodal recurrences led to the patient’s death.

In the patients receiving pelvic node dissection, there were four metastatic and two local recurrences, but the difference in recurrence rates between the two groups was not statistically significant.

“This study leads to the morbidity-sparing approach in cervical cancer treatment while omitting the full pelvic lymph node dissection if the sentinel lymph nodes are negative,” said Dr. Mathevet.

Dr. Mathevet reported no relevant conflicts of interest.

[email protected]

On Twitter @karioakes

NATIONAL HARBOR, MD. – Patients with early cervical cancer with negative sentinel lymph node biopsy who did not receive pelvic lymphadenectomy experienced less postsurgical morbidity than patients who underwent lymphadenectomy, with no drop in overall or recurrence-free survival, investigators report.

In SENTICOL2, a 30-center prospective randomized study that compared sentinel lymph node (SLN) biopsy alone with SLN biopsy plus pelvic lymph node dissection for patients with early cervical cancer, recurrence-free survival at 3 years was 92% for patients receiving SLN only, compared with 95% in patients who had pelvic node dissection.

Overall survival at 3 years was 98% for the SLN-only patients, compared with 99% for those who had pelvic node dissection. None of these differences were statistically significant, and there were no significant differences between the study arms’ non-censored progression-free and overall survival rates at 6 years, Patrice Mathevet, MD, reported at the annual meeting of the Society of Gynecologic Oncology.

The study’s primary objective, said Dr. Mathevet, professor of obstetrics and gynecology at the University of Lausanne, Switzerland, was to compare the surgical morbidity experienced in each study arm, including quality of life and lymphedema–related signs and symptoms. A secondary objective was to assess and compare both overall survival and the 3-year recurrence-free rate for each study arm.

Patients were included if they had cervical cancer at International Federation of Gynecology and Obstetrics stage IA, IB1, or IIA1, with no sign of regional or distant metastases. Pregnant patients were excluded.

SLN scintigraphy was performed using the combined technetium and patent blue dye method. Patients with no identified or unilateral SLNs were excluded from the study and underwent pelvic lymph node dissection, as were patients in whom SLN scintigraphy was not performed.

Once SLNs were identified for the remaining patients, any patients with SLN metastases found on frozen section were excluded as well, while patients with grossly non-suspicious nodes and those with negative nodes on frozen section were randomized to receive just SLN biopsy with or without hysterectomy, or to receive pelvic lymph node dissection with or without hysterectomy.

SLNs in both study arms were examined by 200 micrometer serial sectioning with immunohistochemistry. For the pelvic node dissection arm, the nodes were submitted for pathology examination according to the study institution’s standard of care.

Over a 40-month period from March 2009 to July 2012, 267 patients with early cervical cancer were recruited. In the end, 206 patients were included in the study and 61 patients with positive or absent SLN results became ineligible according to the protocol criteria.

Of the eligible patients, 105 were randomized to the SLN biopsy–only arm, while 101 were allocated to the SLN biopsy plus pelvic lymph node dissection arm. Taking both study arms together, the median number of SLNs taken was three per patient, with a median one node per side.

When Dr. Mathevet and his colleagues looked at pathology from the pelvic lymph node dissection arm, they found that there were no false negatives, meaning that all patients with negative SLNs also had negative pelvic nodes.

Patient quality of life as assessed by the Short Form Health Survey (SF-36) was significantly lower for patients who received pelvic lymph node dissection. Lower extremity lymphedema signs and symptoms were also more common in patients who had pelvic lymph node dissection, indicated by the larger mean mid-thigh circumference and more common patient-reported leg heaviness and leg fatigue in the pelvic node dissection group.

The lymphedema findings were encapsulated in a global lymphatic morbidity score of 33 for the SLN-only group, compared with 52 for the pelvic node dissection group (P = .0046).

“Sentinel lymph node biopsy may improve the management of early cervical cancer, as sentinel lymph node biopsy alone induced less surgical morbidity than full pelvic lymph node dissection,” said Dr. Mathevet.

Patients were followed for a mean of 51 months post-procedure, with a total of 16 patients lost to follow-up. Patients in the SLN-only arm had a total of 11 recurrences, of which 5 were metastatic, 4 were local, and 2 were pelvic nodal. One of the pelvic nodal recurrences led to the patient’s death.

In the patients receiving pelvic node dissection, there were four metastatic and two local recurrences, but the difference in recurrence rates between the two groups was not statistically significant.

“This study leads to the morbidity-sparing approach in cervical cancer treatment while omitting the full pelvic lymph node dissection if the sentinel lymph nodes are negative,” said Dr. Mathevet.

Dr. Mathevet reported no relevant conflicts of interest.

[email protected]

On Twitter @karioakes

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan drug designation for BI 836858, an anti-CD33 monoclonal antibody (mAb), in the treatment of myelodysplastic syndromes (MDS).

BI 836858 previously received orphan designation for the treatment of acute myeloid leukemia (AML).

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases.

This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

About BI 836858

BI 836858 is a fully human, immunoglobulin G1 anti-CD33 mAb. It has been engineered for improved binding to FcgRIIIa to mediate natural killer cell antibody-dependent cellular cytotoxicity against CD33-expressing tumor cells.

BI 836858 is being developed by Boehringer Ingelheim.

A phase 1/2 trial (NCT02240706) of BI 836858 in patients with MDS is ongoing. The phase 1 portion was designed to evaluate various doses of the mAb in patients with low or intermediate-1 risk MDS with symptomatic anemia.

The phase 2 portion was designed to compare BI 836858 plus best supportive care to best supportive care alone in patients with low- or intermediate-1-risk MDS who have symptomatic anemia but do not have a 5q deletion.

BI 836858 is also being tested in combination with decitabine in a phase 1/2 study (NCT02632721) of patients with AML.

The goals of the phase 1 portion and the phase 1 extension are to determine the maximum-tolerated dose/recommended dose, safety, pharmacokinetics, and efficacy of BI 836858 in combination with decitabine.

The goals of the phase 2 portion of the study are to investigate the efficacy, safety, and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

BI 836858 was previously evaluated in combination with decitabine in a preclinical study. The combination exhibited activity against AML in vitro. The research was published in Blood last year.

BI 836858 is also being evaluated as part of the Leukemia & Lymphoma Society’s Beat AML Master Trial program to advance treatment for patients with AML.

In this trial, investigators are using genomic technology to identify AML mutations in newly diagnosed patients over the age of 60 and match the patients with an investigational drug or drugs best suited to attack the mutations found.

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan drug designation for BI 836858, an anti-CD33 monoclonal antibody (mAb), in the treatment of myelodysplastic syndromes (MDS).

BI 836858 previously received orphan designation for the treatment of acute myeloid leukemia (AML).

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases.

This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

About BI 836858

BI 836858 is a fully human, immunoglobulin G1 anti-CD33 mAb. It has been engineered for improved binding to FcgRIIIa to mediate natural killer cell antibody-dependent cellular cytotoxicity against CD33-expressing tumor cells.

BI 836858 is being developed by Boehringer Ingelheim.

A phase 1/2 trial (NCT02240706) of BI 836858 in patients with MDS is ongoing. The phase 1 portion was designed to evaluate various doses of the mAb in patients with low or intermediate-1 risk MDS with symptomatic anemia.

The phase 2 portion was designed to compare BI 836858 plus best supportive care to best supportive care alone in patients with low- or intermediate-1-risk MDS who have symptomatic anemia but do not have a 5q deletion.

BI 836858 is also being tested in combination with decitabine in a phase 1/2 study (NCT02632721) of patients with AML.

The goals of the phase 1 portion and the phase 1 extension are to determine the maximum-tolerated dose/recommended dose, safety, pharmacokinetics, and efficacy of BI 836858 in combination with decitabine.

The goals of the phase 2 portion of the study are to investigate the efficacy, safety, and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

BI 836858 was previously evaluated in combination with decitabine in a preclinical study. The combination exhibited activity against AML in vitro. The research was published in Blood last year.

BI 836858 is also being evaluated as part of the Leukemia & Lymphoma Society’s Beat AML Master Trial program to advance treatment for patients with AML.

In this trial, investigators are using genomic technology to identify AML mutations in newly diagnosed patients over the age of 60 and match the patients with an investigational drug or drugs best suited to attack the mutations found.

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted orphan drug designation for BI 836858, an anti-CD33 monoclonal antibody (mAb), in the treatment of myelodysplastic syndromes (MDS).

BI 836858 previously received orphan designation for the treatment of acute myeloid leukemia (AML).

The FDA grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent rare diseases/disorders affecting fewer than 200,000 people in the US.

Orphan designation provides companies with certain incentives to develop products for rare diseases.

This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

About BI 836858

BI 836858 is a fully human, immunoglobulin G1 anti-CD33 mAb. It has been engineered for improved binding to FcgRIIIa to mediate natural killer cell antibody-dependent cellular cytotoxicity against CD33-expressing tumor cells.

BI 836858 is being developed by Boehringer Ingelheim.

A phase 1/2 trial (NCT02240706) of BI 836858 in patients with MDS is ongoing. The phase 1 portion was designed to evaluate various doses of the mAb in patients with low or intermediate-1 risk MDS with symptomatic anemia.

The phase 2 portion was designed to compare BI 836858 plus best supportive care to best supportive care alone in patients with low- or intermediate-1-risk MDS who have symptomatic anemia but do not have a 5q deletion.

BI 836858 is also being tested in combination with decitabine in a phase 1/2 study (NCT02632721) of patients with AML.

The goals of the phase 1 portion and the phase 1 extension are to determine the maximum-tolerated dose/recommended dose, safety, pharmacokinetics, and efficacy of BI 836858 in combination with decitabine.

The goals of the phase 2 portion of the study are to investigate the efficacy, safety, and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

BI 836858 was previously evaluated in combination with decitabine in a preclinical study. The combination exhibited activity against AML in vitro. The research was published in Blood last year.

BI 836858 is also being evaluated as part of the Leukemia & Lymphoma Society’s Beat AML Master Trial program to advance treatment for patients with AML.

In this trial, investigators are using genomic technology to identify AML mutations in newly diagnosed patients over the age of 60 and match the patients with an investigational drug or drugs best suited to attack the mutations found.

ORLANDO – “Consider the effects of the mind on the skin when treating patients with some skin diseases.” That was the message of several speakers during a session titled “The Skin and the Mind” at the annual meeting of the American Academy of Dermatology.

“I certainly believe that the time has come to use stress alleviation techniques, at least for selected patients, and this should certainly be part of our armamentarium in the clinic,” said Richard D. Granstein, MD, George W. Hambrick Jr. professor and chairman of the department of dermatology, Cornell University, New York. During the session, he spoke about the emerging science of stress in dermatology.

While it has long been believed that stress exacerbates different skin diseases, the connection has been difficult to prove scientifically, he pointed out. However, “the overwhelming number of reports and studies indicate that stress probably does exacerbate a number of inflammatory skin diseases,” he added.

In a video interview at the meeting, Dr. Granstein notes that a number of pathways that help explain this link have now been identified and discusses one of those pathways, which involves neuropeptides and future directions in understanding the relationship between stress and inflammatory skin diseases.

[email protected]
On Twitter @whitneymcknight

ORLANDO – “Consider the effects of the mind on the skin when treating patients with some skin diseases.” That was the message of several speakers during a session titled “The Skin and the Mind” at the annual meeting of the American Academy of Dermatology.

“I certainly believe that the time has come to use stress alleviation techniques, at least for selected patients, and this should certainly be part of our armamentarium in the clinic,” said Richard D. Granstein, MD, George W. Hambrick Jr. professor and chairman of the department of dermatology, Cornell University, New York. During the session, he spoke about the emerging science of stress in dermatology.

While it has long been believed that stress exacerbates different skin diseases, the connection has been difficult to prove scientifically, he pointed out. However, “the overwhelming number of reports and studies indicate that stress probably does exacerbate a number of inflammatory skin diseases,” he added.

In a video interview at the meeting, Dr. Granstein notes that a number of pathways that help explain this link have now been identified and discusses one of those pathways, which involves neuropeptides and future directions in understanding the relationship between stress and inflammatory skin diseases.

[email protected]
On Twitter @whitneymcknight

ORLANDO – “Consider the effects of the mind on the skin when treating patients with some skin diseases.” That was the message of several speakers during a session titled “The Skin and the Mind” at the annual meeting of the American Academy of Dermatology.

“I certainly believe that the time has come to use stress alleviation techniques, at least for selected patients, and this should certainly be part of our armamentarium in the clinic,” said Richard D. Granstein, MD, George W. Hambrick Jr. professor and chairman of the department of dermatology, Cornell University, New York. During the session, he spoke about the emerging science of stress in dermatology.

While it has long been believed that stress exacerbates different skin diseases, the connection has been difficult to prove scientifically, he pointed out. However, “the overwhelming number of reports and studies indicate that stress probably does exacerbate a number of inflammatory skin diseases,” he added.

In a video interview at the meeting, Dr. Granstein notes that a number of pathways that help explain this link have now been identified and discusses one of those pathways, which involves neuropeptides and future directions in understanding the relationship between stress and inflammatory skin diseases.

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MIAMI BEACH – Breast tumors positive for the human epidermal growth factor receptor-2 (HER2) comprise only about 20% of all breast cancers, but for patients with HER2-positive disease, neoadjuvant therapy with trastuzumab (Herceptin) was and is a game changer, improving pathological complete response rates and long-term disease-free and overall survival rates, Debu Tripathy, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In the nearly 2 decades that have passed since the approval of trastuzumab, clinicians have learned how best to use HER2 inhibitors, how to weigh the relative risks and benefits of anti-HER2 therapy in patients who may be at risk for cardiotoxicities such as heart failure, and what combination regimens work best with HER2 inhibitors in early-stage disease.

In a video interview, Dr. Tripathy, professor and chair of the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston, discusses current clinical considerations for the use of trastuzumab and pertuzumab (Perjeta) in the neoadjuvant and adjuvant settings, investigational targeted therapies and immunotherapeutic strategies, and recently released clinical trial data showing a significant increase in disease-free survival for patients treated with dual HER2-blockade compared with HER2 monotherapy.

MIAMI BEACH – Breast tumors positive for the human epidermal growth factor receptor-2 (HER2) comprise only about 20% of all breast cancers, but for patients with HER2-positive disease, neoadjuvant therapy with trastuzumab (Herceptin) was and is a game changer, improving pathological complete response rates and long-term disease-free and overall survival rates, Debu Tripathy, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In the nearly 2 decades that have passed since the approval of trastuzumab, clinicians have learned how best to use HER2 inhibitors, how to weigh the relative risks and benefits of anti-HER2 therapy in patients who may be at risk for cardiotoxicities such as heart failure, and what combination regimens work best with HER2 inhibitors in early-stage disease.

In a video interview, Dr. Tripathy, professor and chair of the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston, discusses current clinical considerations for the use of trastuzumab and pertuzumab (Perjeta) in the neoadjuvant and adjuvant settings, investigational targeted therapies and immunotherapeutic strategies, and recently released clinical trial data showing a significant increase in disease-free survival for patients treated with dual HER2-blockade compared with HER2 monotherapy.

MIAMI BEACH – Breast tumors positive for the human epidermal growth factor receptor-2 (HER2) comprise only about 20% of all breast cancers, but for patients with HER2-positive disease, neoadjuvant therapy with trastuzumab (Herceptin) was and is a game changer, improving pathological complete response rates and long-term disease-free and overall survival rates, Debu Tripathy, MD, said at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

In the nearly 2 decades that have passed since the approval of trastuzumab, clinicians have learned how best to use HER2 inhibitors, how to weigh the relative risks and benefits of anti-HER2 therapy in patients who may be at risk for cardiotoxicities such as heart failure, and what combination regimens work best with HER2 inhibitors in early-stage disease.

In a video interview, Dr. Tripathy, professor and chair of the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston, discusses current clinical considerations for the use of trastuzumab and pertuzumab (Perjeta) in the neoadjuvant and adjuvant settings, investigational targeted therapies and immunotherapeutic strategies, and recently released clinical trial data showing a significant increase in disease-free survival for patients treated with dual HER2-blockade compared with HER2 monotherapy.

ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.

In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.

For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.

Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.

“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”

Despite these questions, the committee continued to back the WHO recommendations.

Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.

“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”

None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.

[email protected]
On Twitter @EAZTweets

ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.

In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.

For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.

Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.

“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”

Despite these questions, the committee continued to back the WHO recommendations.

Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.

“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”

None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.

[email protected]
On Twitter @EAZTweets

ROCKVILLE, MD. – A committee of Food and Drug Administration advisers backed the World Health Organization’s influenza vaccine recommendations for the 2017-2018 season at a meeting March 9.

In a unanimous vote, members of the Vaccines and Related Biological Products Advisory Committee recommended that trivalent vaccines for the 2017-2018 season should contain the following vaccine strains: A/Michigan/45/2015(H1N1)pdm09-like, A/Hong Kong/4801/2014(H3N2)-like, and B/Brisbane/60/2008-like.

For the influenza B virus, the Yamagata lineage and Victoria lineage strain cycled monthly as the predominant strain in the 2016-2017 season, with a split of “around 50/50,” leaning toward Yamagata in North America, Europe, and Oceana, Dr. Katz explained. The Victoria lineage, in some cases, accounted for nearly 75% of B viruses in Africa and South America.

Committee members expressed concern over the difference between strain prevalence in the United States and abroad and considered recommending a strain that did not coincide with the WHO recommendation, something that has not happened in the history of the advisory committee.

“I’m very aware of influenza vaccinations being a global enterprise, and companies manufacture vaccines for use in multiple countries,” said Committee Chair Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University, Nashville, Tenn. “If we to select a B strain that differed from the WHO recommendation, would that adversely impact vaccine production for the U.S. market?”

Despite these questions, the committee continued to back the WHO recommendations.

Historically, the advisory committee has recommended flu vaccine strains earlier in the year, according to Beverly Taylor, PhD, head of influenza scientific affairs and pandemic readiness at Seqirus Vaccines. Dr. Taylor presented the vaccine manufacturers’ perspective. The delay has put added pressure on manufacturers.

“We haven’t seen impacts yet on start of vaccination dates,” said Dr. Taylor. “But the very clear message from manufacturers is if you keep squashing that manufacturing window, then there will reach a point where we are concerned we will see an impact on vaccine supply time.”

None of the committee members presented waivers of conflict of interest. While the FDA is not obligated to follow the recommendations of the advisory committee, it generally does.

[email protected]
On Twitter @EAZTweets

MIAMI BEACH – Although typically not as immunogenic as melanoma or lung cancer, breast cancer can respond to immunotherapy. Promising strategies in development each aim to optimize an individual patient’s ability to respond to immunotherapy in advance.

Augmenting infiltration of T cells into the breast so their levels will be high enough to mount a formidable response is one tactic. In addition, preimmunotherapy radiation or cryoimmunotherapy to release neoantigens – so the immune system has something to which to respond – are additional avenues being explored, Elizabeth A. Mittendorf, MD, PhD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

MIAMI BEACH – Although typically not as immunogenic as melanoma or lung cancer, breast cancer can respond to immunotherapy. Promising strategies in development each aim to optimize an individual patient’s ability to respond to immunotherapy in advance.

Augmenting infiltration of T cells into the breast so their levels will be high enough to mount a formidable response is one tactic. In addition, preimmunotherapy radiation or cryoimmunotherapy to release neoantigens – so the immune system has something to which to respond – are additional avenues being explored, Elizabeth A. Mittendorf, MD, PhD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.

MIAMI BEACH – Although typically not as immunogenic as melanoma or lung cancer, breast cancer can respond to immunotherapy. Promising strategies in development each aim to optimize an individual patient’s ability to respond to immunotherapy in advance.

Augmenting infiltration of T cells into the breast so their levels will be high enough to mount a formidable response is one tactic. In addition, preimmunotherapy radiation or cryoimmunotherapy to release neoantigens – so the immune system has something to which to respond – are additional avenues being explored, Elizabeth A. Mittendorf, MD, PhD, said in a video interview at the annual Miami Breast Cancer Conference, held by Physicians’ Education Resource.