Exelixis, Inc. (NASDAQ:EXEL) just announced top-line results from the final analysis of its COMET-1 Phase 3 pivotal trial of cabozantinib (Cometriq) in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. Unfortunately, the trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival compared to control patients treated with standard prednisone therapy. While the results were in a favorable direction, they weren't strong enough to meet the statistical cutpoints required for success. The main statistic, which has sent the stock plummeting 54% at the time of this writing is that the median overall survival for the cabozantinib arm of the trial was 11.0 months versus 9.8 months for the prednisone arm. This resulted in a hazard ratio of 0.90 (95% CI 0.76, 1.06). The secondary endpoint of progression-free survival (which has never been used as a basis for approving a prostate cancer drug) was 5.5 months for the cabozantinib arm of the trial versus 2.8 months for the prednisone arm. These results were significant, generating a hazard ratio of 0.50 (95% CI 0.42, 0.60).
In an article I published a few weeks ago, I had argued that......READ FULL ARTICLE
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