Bayer's regorafenib Phase 3 trial on metastatic colorectal cancer meets primary endpoint

Oct 27 2011

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from a Bayer HealthCare Pharmaceuticals Phase 3 trial evaluating the investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies. The trial met its primary endpoint of statistically significant improvement in overall survival. This is the result of a pre-planned interim analysis conducted by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Per the recommendation of the DMC, the study has been unblinded and patients in the placebo arm will be offered treatment with regorafenib. In this trial, the safety and tolerability of regorafenib were generally as expected.  Data from the study are expected to be presented at a forthcoming scientific meeting.

Onyx recently entered into an agreement with Bayer under which Bayer will pay Onyx a royalty on any future global net sales of regorafenib in oncology.

"Patients with metastatic colorectal cancer are in need of new treatment options, and these data demonstrate that regorafenib increased overall survival," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "We look forward to seeing this promising therapy become available to patients as quickly as possible."

Bayer will continue discussions with health authorities worldwide, including the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), regarding next steps in filing for approval of regorafenib in the treatment of mCRC.