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Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer


South San Francisco, Calif. -- March 11, 2010 -- Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the topline results of a Phase III trial led by the U.S. Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI) investigating the use of Avastin® (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone. A preliminary assessment of safety performed by CALGB has shown adverse events that have been previously observed in pivotal trials with Avastin. Data from the study will be submitted by CALGB for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints," said Hal Barron, M.D., head, Global Development and chief medical officer at Roche.

These findings do not impact Avastin's approved uses or its broad development program in other tumor types.

About Prostate Cancer
Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate cancer and approximately 27,000 died from the disease in the United States.

About CALGB 90401
CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate Avastin plus docetaxel chemotherapy and prednisone, compared to docetaxel chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the NCI under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB.

The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival, prostate-specific antigen response rate and safety.

Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.

http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12667