Exelixis, Inc. COMET-2 Ph3 Cabozantinib Trial Fails To Meet Primary Endpoint

Published: Dec 02, 2014

Exelixis COMET-2 Ph3 Cabozantinib Trial Fails To Meet Primary Endpoint

December 1, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Exelixis, Inc. , a California-based biopharmaceutical company, announced today that its Phase III trial of cabozantinib did not meet its primary endpoint. Cabozantinib, which is marketed as COMETRIQ, has been approved by the U.S. Food and Drug Administration to treat progressive, metastatic medullary thyroid cancer.

The Phase III trial, titled COMET-2, was a double-blind, randomized controlled study of the drug in men who have metastatic castration-resistant prostate cancer, in addition to moderate to severe pain. The primary endpoint was defined as the alleviation of bone pain, but the drug did not meet this endpoint in the study.

“Following the COMET-1 top-line results announced in September, we deprioritized the cabozantinib development program in mCRPC; at that time, we also initiated a significant workforce reduction in order to focus our development efforts and financial resources on the pivotal phase 3 studies of cabozantinib in metastatic renal cell carcinoma (RCC) and advanced hepatocellular carcinoma,” said Michael Morrissey, president and chief executive officer of Exelixis. “With target enrollment in the METEOR study in RCC recently achieved, we anticipate top-line results in the second quarter of 2015. We also look forward to Roche and Genentech’s continued regulatory progress with cobimetinib for metastatic melanoma. The EU review is underway and the U.S. filing is expected before year-end, which could ultimately lead to our opportunity to co-promote cobimetinib in the U.S. if it is approved for this indication.”

Cabozantinib works by inhibiting the activity of tyrosine kinases within the body. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes including tumor angiogenesis.

COMET-1 Study Results
Back in September, Exelixis announced the results of its COMET-1 study, which was designed to analyze how cabozantinib impacted men who have metastatic castration-resistant prostate cancer. By the end of this study, cabozantinib had not reached its primary endpoint, which was to significantly increase the overall survival rate.

“We are very disappointed that COMET-1 did not meet its primary endpoint of extending overall survival in men with mCRPC,” said Morrissey, at the time of the announcement. “We are grateful to the patients, physicians, nurses, caregivers, and other study team members who participated in the trial. We remain focused on the development program for cabozantinib beyond mCRPC, including the ongoing METEOR and CELESTIAL phase 3 pivotal trials, from which we expect top-line data in 2015 and 2017, respectively.”

COMET-1 was a randomized, double-blind, controlled trial that enrolled 960 patients. The individuals who participated had been previously treated with docetaxel, abiraterone and/or enzalutamide.

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