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news.Genentech, a wholly owned member of the Roche Group, has presented the results of a Phase III trial led by the US Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI).
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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.
Genentech said that the study, 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.
The findings do not impact Avastin’s approved uses or its broad development program in other tumor types. 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.
Genentech said that the 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.
Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF). VEGF plays a role throughout the lifecycle of the tumor to develop and maintain blood vessels, known as angiogenesis process.
Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).
Hal Barron, head of global development and chief medical officer at Roche, said: “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.”