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Exelixis Initiates COMET-1 Pivotal Trial Focused on Overall Survival in Men With Advanced Prostate Cancer


Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of COMET-1, a phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint for COMET-1 is overall survival (OS) in mCRPC patients who have had disease progression after treatment with docetaxel and abiraterone acetate and/or MDV3100. Exelixis expects data from COMET-1 to be available in the first half of 2014.

“COMET-1 is a well-designed global study of a compound with the potential to address many of the unmet medical needs for men with mCRPC,” said Matthew R. Smith, M.D., Ph.D., director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center and lead investigator for COMET-1. “The phase 2 studies of cabozantinib provide early evidence of impressive effects on measurable tumor, progression-free survival, bone scan response, pain alleviation, and circulating tumor cell (CTC) counts. Several of these measures, including reduction in pain and CTC counts, are associated with improved overall survival in mCRPC. If COMET-1 confirms these early findings and demonstrates a survival benefit, I believe cabozantinib could become an important new treatment option for men with mCRPC.”

Posted-In: News FDA


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