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Cabozantinib (Conetriq) Fails Pivotal Study in Men With Metastatic Castration-Resistant Prostate Cancer
Disappointing results have been reported from the final analysis of COMET-2, a phase III, randomized, double-blind, controlled trial of cabozantinib (Conetriq, Exelixis, Inc.) in men with metastatic castration-resistant prostate cancer (mCRPC) who were experiencing moderate-to-severe pain despite optimized narcotic medication, and whose disease had progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide.
The trial did not meet its primary endpoint of alleviation of bone pain, as 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.
Fifteen percent of patients in the cabozantinib arm reported a pain response compared with 17% of patients in the control arm (mitoxantrone/prednisone). The difference in pain responses between the two treatment arms was not statistically significant.
In the COMET-2 study, 119 patients were randomly assigned to receive either cabozantinib or mitoxantrone/prednisone. In addition to the primary endpoint of alleviation of bone pain, secondary endpoints included the bone-scan response and overall survival.
Cabozantinib inhibits the activity of tyrosine kinases, including MET, RET, and vascular endothelial growth-factor receptors (VEGFRs). These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes, such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Cometriq (cabozantinib) is approved by the FDA for the treatment of progressive, metastatic medullary thyroid cancer.
Source: Exelixis, Inc.; December 1, 2014.