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New NCI Director, Early Release of Prostate Cancer Data, Disappointing Findings in RCC Trial, and More

Gina Columbus
Published Online: Friday, Jun 16, 2017



Today-

A new director for the National Cancer Institute, an early release of data in prostate cancer, disappointing findings in a renal cell carcinoma trial, enrollment paused in 2 multiple myeloma studies, and discontinuation of a phase III colorectal cancer trial.

Welcome to OncLive News Network! I’m Gina Columbus.

Norman (Ned) E. Sharpless has been named as the next director of the National Cancer Institute.

Sharpless is currently director of the University of North Carolina at Chapel Hill’s Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research. He replaces Douglas Lowy, MD, who has been acting director since April 2015. Lowy will continue to work with the NCI as a deputy director and researcher.

The appointment does not require confirmation by the US Senate.

Sharpless is an attending hematologist/oncologist at the North Carolina Cancer Hospital and has served as director of UNC Lineberger since January 2014. He also co-directs UNCseq, which is a large UNC human clinical trial using next-generation sequencing of tumor DNA to define optimal chemotherapy in patients with advanced cancer in real time.

Former UNC Lineberger director H. Shelton Earp, MD, will return to the position on an interim basis while the center looks for a permanent leader.

*****************************************

Astellas Pharma and Pfizer have announced that phase III results from the PROSPER trial of enzalutamide in men with nonmetastatic castration-resistant prostate cancer will be released later this year. Previously, those data weren’t scheduled for release until June 2019.

This new protocol revises the planned analyses of the primary and several secondary endpoints, reducing the target patient population to 1440 patients, down from 1560.

PROSPER is a multinational, randomized, double blind, placebo-controlled trial exploring the efficacy and safety of enzalutamide. Patients in the experimental arm are assigned to 160 mg daily of oral enzalutamide. The primary endpoint is metastatic-free survival, while secondary endpoints include overall survival, time to prostate-specific antigen progression, and time to chemotherapy-free survival.

The FDA approved enzalutamide in 2012 as a treatment for men with late-stage CRPC previously treated with docetaxel. In 2014, the agency approved the drug for first-line therapy based on results from the phase III PREVAIL trial, in which enzalutamide improved OS by 29% and radiographic progression-free survival by 81% compared with placebo.

The FDA expanded enzalutamide’s label again in 2016 based on findings from the phase II TERRAIN trial, in which enzalutamide reduced the risk of radiographic progression or death by 40% versus bicalutamide, and improved median rPFS by 6.1 months in patients with metastatic CRPC.

*****************************************

In renal cell carcinoma, the combination of dalantercept plus axitinib failed to significantly improve progression-free survival in patients with advanced disease compared with placebo.

According to results from the phase II DART trial, the median PFS for dalantercept plus axitinib was 6.8 months versus 5.6 months for placebo plus axitinib, and the experimental combination did not reduce the rate of disease progression or death.

Acceleron Pharma, the manufacturer of dalantercept, announced that it is ending development of the ALK1-receptor fusion protein that acts as a ligand trap for bone morphogenetic proteins 9 and 10.

Frequency of grade 3 or higher adverse events, regardless of causality, were similar between the 2 groups.

********************************

Merck has announced that it is pausing enrollment of two clinical trials investigating its PD-1 inhibitor pembrolizumab as a potential treatment for patients with multiple myeloma due to patient deaths on the experimental arm.

An external Data Monitoring Committee recommended halting new enrollment while the company collects more data to better understand reported deaths in the pembrolizumab arms. This decision strictly affects KEYNOTE-183 and KEYNOTE-185 and no other pembrolizumab studies.

KEYNOTE-183 is comparing the combination of pembrolizumab, pomalidomide, and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have undergone at least 2 lines of prior treatment.

KEYNOTE-185 is comparing pembrolizumab, lenalidomide and low-dose dexamethasone with lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant.

********************************

Finally, the phase III XCITE study of MABp1 in patients with advanced colorectal cancer has been cancelled by its manufacturer XBiotech after a second prospectively planned, unblinded analysis.

In its statement announcing the decision, XBiotech said its independent data monitoring committee determined that data were not sufficient to meet efficacy or the threshold for continuation.

The committee did not have safety concerns about MABp1, which is a novel monoclonal antibody that specifically targets anti–interleukin 1-alpha. This is a potent inflammatory mediator of chronic inflammation that is secreted by cells in response to infection or injury and by many tumor types.

Results from XCITE were presented at the 2016 World Congress of Gastrointestinal Cancer, but even at that time, healthcare professionals questioned the data.

XBiotech said it is continuing with other studies exploring MABp1, including a phase III European study in metastatic colorectal cancer that was presented at the 2017 ASCO Annual Meeting.

*****************************************

This week, Dr. Daniel George of Duke Cancer Institute discussed the biggest challenges and unmet needs in the field of prostate cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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Today-

A new director for the National Cancer Institute, an early release of data in prostate cancer, disappointing findings in a renal cell carcinoma trial, enrollment paused in 2 multiple myeloma studies, and discontinuation of a phase III colorectal cancer trial.

Welcome to OncLive News Network! I’m Gina Columbus.

Norman (Ned) E. Sharpless has been named as the next director of the National Cancer Institute.

Sharpless is currently director of the University of North Carolina at Chapel Hill’s Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research. He replaces Douglas Lowy, MD, who has been acting director since April 2015. Lowy will continue to work with the NCI as a deputy director and researcher.

The appointment does not require confirmation by the US Senate.

Sharpless is an attending hematologist/oncologist at the North Carolina Cancer Hospital and has served as director of UNC Lineberger since January 2014. He also co-directs UNCseq, which is a large UNC human clinical trial using next-generation sequencing of tumor DNA to define optimal chemotherapy in patients with advanced cancer in real time.

Former UNC Lineberger director H. Shelton Earp, MD, will return to the position on an interim basis while the center looks for a permanent leader.

*****************************************

Astellas Pharma and Pfizer have announced that phase III results from the PROSPER trial of enzalutamide in men with nonmetastatic castration-resistant prostate cancer will be released later this year. Previously, those data weren’t scheduled for release until June 2019.

This new protocol revises the planned analyses of the primary and several secondary endpoints, reducing the target patient population to 1440 patients, down from 1560.

PROSPER is a multinational, randomized, double blind, placebo-controlled trial exploring the efficacy and safety of enzalutamide. Patients in the experimental arm are assigned to 160 mg daily of oral enzalutamide. The primary endpoint is metastatic-free survival, while secondary endpoints include overall survival, time to prostate-specific antigen progression, and time to chemotherapy-free survival.

The FDA approved enzalutamide in 2012 as a treatment for men with late-stage CRPC previously treated with docetaxel. In 2014, the agency approved the drug for first-line therapy based on results from the phase III PREVAIL trial, in which enzalutamide improved OS by 29% and radiographic progression-free survival by 81% compared with placebo.

The FDA expanded enzalutamide’s label again in 2016 based on findings from the phase II TERRAIN trial, in which enzalutamide reduced the risk of radiographic progression or death by 40% versus bicalutamide, and improved median rPFS by 6.1 months in patients with metastatic CRPC.

*****************************************

In renal cell carcinoma, the combination of dalantercept plus axitinib failed to significantly improve progression-free survival in patients with advanced disease compared with placebo.

According to results from the phase II DART trial, the median PFS for dalantercept plus axitinib was 6.8 months versus 5.6 months for placebo plus axitinib, and the experimental combination did not reduce the rate of disease progression or death.

Acceleron Pharma, the manufacturer of dalantercept, announced that it is ending development of the ALK1-receptor fusion protein that acts as a ligand trap for bone morphogenetic proteins 9 and 10.

Frequency of grade 3 or higher adverse events, regardless of causality, were similar between the 2 groups.

********************************

Merck has announced that it is pausing enrollment of two clinical trials investigating its PD-1 inhibitor pembrolizumab as a potential treatment for patients with multiple myeloma due to patient deaths on the experimental arm.

An external Data Monitoring Committee recommended halting new enrollment while the company collects more data to better understand reported deaths in the pembrolizumab arms. This decision strictly affects KEYNOTE-183 and KEYNOTE-185 and no other pembrolizumab studies.

KEYNOTE-183 is comparing the combination of pembrolizumab, pomalidomide, and low-dose dexamethasone with pomalidomide and low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have undergone at least 2 lines of prior treatment.

KEYNOTE-185 is comparing pembrolizumab, lenalidomide and low-dose dexamethasone with lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant.

********************************

Finally, the phase III XCITE study of MABp1 in patients with advanced colorectal cancer has been cancelled by its manufacturer XBiotech after a second prospectively planned, unblinded analysis.

In its statement announcing the decision, XBiotech said its independent data monitoring committee determined that data were not sufficient to meet efficacy or the threshold for continuation.

The committee did not have safety concerns about MABp1, which is a novel monoclonal antibody that specifically targets anti–interleukin 1-alpha. This is a potent inflammatory mediator of chronic inflammation that is secreted by cells in response to infection or injury and by many tumor types.

Results from XCITE were presented at the 2016 World Congress of Gastrointestinal Cancer, but even at that time, healthcare professionals questioned the data.

XBiotech said it is continuing with other studies exploring MABp1, including a phase III European study in metastatic colorectal cancer that was presented at the 2017 ASCO Annual Meeting.

*****************************************

This week, Dr. Daniel George of Duke Cancer Institute discussed the biggest challenges and unmet needs in the field of prostate cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
 
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