Cometriq fails to meet primary endpoint in Prostate Cancer trial-Exelixis

Exelixis has announced top-line results from the final analysis of COMET-1, the Phase III pivotal trial of Cometriq (cabozantinib) in men with metastatic castration-resistant Prostate Cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of demonstrating 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 11.0 months versus 9.8 months for the prednisone arm. The COMET-1 results are the subject of ongoing analyses.

Exelixis will submit additional data, including secondary and exploratory endpoints, for presentation at a future medical conference. Besides OS, the exploratory endpoint of progression-free survival (PFS) also assessed. Median PFS was 5.5 months for the cabozantinib arm of the trial versus 2.8 months for the prednisone arm. Safety data were consistent with those observed in earlier-stage trials of cabozantinib in mCRPC. Based on the outcome of COMET-1, Exelixis has deprioritized the clinical development of cabozantinib in mCRPC. Enrollment in COMET-2, which is the second pivotal trial in mCRPC and evaluates pain palliation, has been halted. The company expects top-line data before the end of this year.