Shares of Exelixis, Inc. (EXEL) dropped 10.2% after the company announced that the trial COMET-2 on cabozantinib did not meet its primary endpoint.
The trial was conducted among men with metastatic castration-resistant prostate cancer (mCRPC) who are suffering from moderate-to-severe pain despite optimized narcotic medication, and whose disease has progressed following treatment with docetaxel as well as Zytiga (abiraterone) and/or Xtandi (enzalutamide).
The primary endpoint of the randomized, double-blind, controlled trial, COMET-2, was an alleviation of bone pain. This was 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 an increase in narcotic medication.
The top-line results from the final analysis of the trial showed that only 15% of the patients in the cabozantinib arm reported a pain response compared to 17 percent of patients in the control arm receiving mitoxantrone/prednisone. Hence, the difference in pain response between the arms was declared as statistically insignificant.
Our Take
We remind investors that the COMET-1 study had also failed to meet the primary endpoint as announced by the company in Sep 2014.
Following the announcement of the disappointing results from the COMET-1 study, Exelixis halted its enrollment process for the COMET-2 study.
The failure of the trial was disappointing for Exelixis. With both trials in the COMET program failing to achieve the primary endpoint, we expect the company to discontinue the evaluation of cabozantinib for the mCRPC indication.
Exelixis decided to reduce its workforce by almost 70% to utilize its resources for other late-stage studies on cabozantinib in metastatic renal cell carcinoma (RCC) and advanced hepatocellular carcinoma. The target enrolment in the METEOR study for RCC has been achieved and top-line results are anticipated in the second quarter of 2015.
Meanwhile, Exelixis has a partnership with Roche (RHHBY) for pipeline candidate cobimetinib for metastatic melanoma. The candidate is under review in the EU and filing in the U.S. is expected before 2014 end.
Exelixis carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the health care sector may consider companies like Valeant Pharmaceuticals (VRX) and Pluristem Therapeutics (PSTI). Both carry a Zacks Rank #1 (Strong Buy).
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