Exelixis, Inc. Chops 70 Percent Of Workforce After Prostate Drug Cabozantinib Fails Pivotal Study
September 2, 2014
By Mark Terry, BioSpace.com Breaking News Staff
After disappointing results of a phase 3 clinical trial, Exelixis, Inc. announced it will reduce its workforce by about 70%, or approximately 160 people. Based in South San Francisco, California, Exelixis, Inc. announced that their top-line results from its COMET-1 phase 3 clinical trial of cabozantinib did not meet its primary endpoint.
The COMET-1 trial was a randomized, double-blind, controlled trial with approximately 960 patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel, as well as abiraterone and/or enzalutamide. Patients were randomized 2 to 1 to receive 60 mg daily of cabozantinib or 5 mg twice daily of prednisone. The primary endpoint was Overall Survival (OS). The secondary endpoint was bone scan response, which was assessed by a committee of independent radiologists.
COMETRIQ® (cabozantinib) has been approved by the U.S. FDA for the treatment of progressive, metastatic medullary cancer, and for conditional use in the treatment of adult patients with progressive, unresectable locally advanced metastatic thyroid cancer (MTC) in the European Union. The drug inhibits the activity of tyrosine kinases, including MET, VEGFRs, and RET.
The COMET-1 trial did not demonstrate statistically significant increases in overall survival with treatment with cabozantinib versus treatment with prednisone. Median OS for cabozantinib was 11.0 months, and 9.8 months for the prednisone arm. As a result, Exelixis is shifting its focus and financial resources toward the late-stage clinical trials of cabozantinib in metastatic renal cell carcinoma, dubbed the METEOR trial, and toward advanced hepatocellular carcinoma, named the CELESTIAL trial. It has ceased enrollment in COMET-2, which was a pivotal trial in mCRPC that evaluated pain palliation. Other studies related to mCRPC and cabozantinib will also cease.
As a result of the workforce reduction, Exelixis, indicates it expects to have enough cash to support its operations through the end of the METEOR trial at the end of 2014. In a press release, Exelixis President and CEO Michael M. Morrissey, PhD, stated, “We are very 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. We remain focused on the development program for cabozanitinib beyond mCRPC, including the ongoing METEOR and CELESTIAL phase 3 pivotal trials, from which we expected top-line data in 2015 and 2017, respectively.”
On July 31, Exelixis reported net revenues in Q2 of $6.6 million, made up mostly of revenue from the sales of COMETRIQ. In the previous year’s Q2, the company reported $11.9 million, of which about $4.0 million consisted of COMETRIQ sales and $7.8 million of license and contract revenue. Net loss for the 2014 Q2 was $73.4 million.