Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer
South San Francisco, Calif. — 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.
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