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Genentech Announces Topline Results of Phase III Trial for Avastin in Late Stage Prostate Cancer

Strategic Insights

— 2 min read

Genentech, a member of the Roche Group, has announced the topline results of a Phase III trial investigating the use of Avastin in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer. The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone. However, the data from the study will be submitted for presentation at the American Society of Clinical Oncology annual meeting in June 2010.

Key Takeaways:

  • The study, CALGB 90401, was a multicenter, randomized, double-blinded, placebo-controlled Phase III trial 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 primary endpoint of the study was overall survival, while secondary endpoints included progression-free survival, prostate-specific antigen response rate, and safety.
  • The trial is sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the U.S. Cancer and Leukemia Group B (CALGB).
  • A preliminary assessment of safety performed by CALGB has shown severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.
  • These findings do not impact Avastin's approved uses or its broad development program in other tumor types.
  • Hal Barron, M.D., head, Global Development and chief medical officer at Roche, stated, "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."
  • The study highlights the challenges of developing effective treatments for late stage prostate cancer, with an estimated 192,000 men diagnosed and approximately 27,000 deaths in the United States in 2009.

Statistics:

  • The study involved 1,050 men with hormone-refractory prostate cancer.
  • The primary endpoint of the study was overall survival.
  • A preliminary assessment of safety performed by CALGB identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections (0.3% to 2.4%).
  • Data from the study will be submitted for presentation at the American Society of Clinical Oncology annual meeting in June 2010.

Sources:

  • Genentech, Inc. (2010). Genentech Announces Topline Results of Phase III Trial for Avastin in Late Stage Prostate Cancer.
  • American Cancer Society (2009). Cancer Facts & Figures 2009.
  • National Cancer Institute (2010). CALGB 90401: A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial Evaluating Avastin Plus Docetaxel Chemotherapy and Prednisone Versus Docetaxel Chemotherapy and Prednisone Alone in Patients with Hormone-Refractory Prostate Cancer.

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