Cometriq Fails to Meet Primary Endpoint in Metastatic Castration-Resistant Prostate Cancer

Cometriq Fails to Meet Primary Endpoint in Metastatic Castration-Resistant Prostate Cancer
prostate cancer drugExelixis, Inc. has announced the results from its COMET-1 phase 3 trial on cabozantinib for the treatment of metastatic castration-resistant prostate cancer (mCRPC) did not meet the primary endpoint of overall survival (OS) when compared with prednisone treatment. Cabozantinib (COMETRIQ) is a U.S. Food and Drug Administration approved drug for the treatment of progressive, metastatic medullary thyroid cancer, which inhibits the activity of tyrosine kinases involved in both normal cellular functions and pathologic oncogenic processes such as metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment. COMET-1 was a randomized, double-blind, controlled trial that enrolled 960 patients with mCRPC suffering from bone metastases, who had previously been treated with docetaxel, abiraterone or enzalutamide, and whose cancer progressed after treatment. Patients were randomized to receive either cabozantinib or prednisone, an immunosuppressant corticosteroid. The primary endpoint of the trial was set to OS, and the secondary endpoint was bone scan response as assessed by an independent radiology committee. The COMET-1 results are still under analysis since in addition to OS, progression-free survival (PFS) is the only time-to-event-based endpoint for which data are available, with a median PFS of 5.5 months for the cabozantinib arm ve
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