Exelixis, Inc. (NASDAQ:EXEL) announced that the Independent Data Monitoring Committee (IDMC) notified the company today that a planned interim analysis of the COMET-1 phase 3 pivotal trial has been completed, and that the IDMC recommended the trial proceed to its final analysis. Exelixis continues to anticipate top-line data from COMET-1 in 2014.
About the COMET-1 Trial
COMET-1 is a randomized, double-blind, controlled trial designed to enroll 960 patients with mCRPC who have progressed after treatment with docetaxel, abiraterone and/or enzalutamide. All patients in the trial have bone metastases and there is no limit to the number or type of prior treatments. Patients were randomized 2:1 to receive cabozantinib (60 mg daily) or prednisone (5 mg twice daily). The trial is event-driven and has 90% power to detect a 25% reduction in the risk of death (HR = 0.75) at the time of final analysis, which requires 578 events. The current interim analysis after 387 events was also planned to assess if the trial achieved its primary endpoint; it did not include a futility analysis. The secondary endpoint of the trial is bone scan response as assessed by an independent radiology facility (IRF).
Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
COMETRIQ® (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer.
The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.