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news.US-based biopharmaceutical firm Exelixis has released top-line results from the final analysis of the Phase III COMET-1 trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC).
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The COMET-1 trial evaluated cabozantinib in mCRPC patients whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide.
The trial failed to meet its primary endpoint of showing a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.
The median OS for the cabozantinib arm of the trial was 11 months versus 9.8 months for the prednisone arm.
Apart from the OS, the exploratory endpoint of progression-free survival (PFS) as evaluated by the investigators is the only time-to-event-based endpoint for which data are available.
Based on the outcome of the COMET-1 trial, the company plans to initiate a significant workforce reduction that will help in focusing on its financial resources on the late-stage clinical trials of cabozantinib in metastatic renal cell carcinoma (the METEOR trial) and advanced hepatocellular carcinoma (the CELESTIAL trial).
Exelixis president and chief executive officer Michael Morrissey said the company is disappointed that COMET-1 did not meet its primary endpoint of extending overall survival in men with mCRPC.
"We are grateful to the patients, physicians, nurses, caregivers, and other study team members who participated in the trial," Morrissey said.
"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."
Based on the outcome of trial, the company has deprioritised the clinical development of cabozantinib in mCRPC.