Exelixis: COMET-2 Trial Of Cabozantinib Fails To Meet Primary Endpoint

(RTTNews) - Exelixis Inc. (EXEL) announced top-line results from the final analysis of COMET-2, a randomized, double-blind, controlled trial of cabozantinib in men with metastatic castration-resistant prostate cancer who are suffering from moderate to severe pain despite optimized narcotic medication, and whose disease has progressed following treatment with docetaxel as well as abiraterone and/or enzalutamide. The company said the trial did not meet its primary endpoint of alleviation of bone pain, as determined by comparing the percentage of patients in the two treatment arms who achieved a pain response at Week 6 that was confirmed at Week 12 without increase in narcotic medication. Fifteen percent of patients in the cabozantinib arm reported a pain response, compared to 17 percent of patients in the control arm receiving mitoxantrone/ prednisone. The difference in pain response between the arms was not statistically significant, the company said.

The company reported that the safety profile of cabozantinib in the trial was consistent with that observed in previous studies in mCRPC.