publication date: Apr. 30, 2015
20150430 - Apr. 30, 2015
April 2015PDF

 

Melanoma

Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial

A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study’s independent data monitoring committee recommended stopping the trial early.

In the trial, named KEYNOTE-006, Keytruda (pembrolizumab) improved PFS by 42 percent and extended overall survival by 34 percent compared to Yervoy (ipilimumab).

Investigators from 16 countries enrolled 834 patients with metastatic melanoma in the clinical trial, and patients were randomly assigned to Keytruda and Yervoy. The study was published online in the New England Journal of Medicine, and was presented at the annual meeting of the American Association for Cancer Research. The trial was sponsored by Merck.

 

Prostate Cancer

Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.

The companies also published data from two separate phase II head-to-head studies, named STRIVE and TERRAIN, comparing Xtandi (enzalutamide) to Casodex (bicalutamide).

The phase III trial, named PREVAIL, was a randomized, double-blind trial that enrolled 1,717 patients at sites in the U.S., Canada, Europe, Australia, Russia, Israel and Asia, including Japan.

 

Drugs and Targets

FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data

FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.

The update was based on the final analysis of the phase III, randomized, double-blind, placebo-controlled COU-AA-302 study, which showed that Zytiga plus prednisone significantly prolonged median overall survival, compared to placebo plus prednisone. 

 

Breast Cancer

Ongoing Phase II Trial Shows Correlation Between Immune Response and Recurrence

 

Lymphoma

Circulating Tumor Cells Can Be Used to Detect DLBCL Recurrence, Researchers Say

 NCI CTEP-Approved Trials for the Month of April 
  

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