Onyx announces results from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from the Phase 3 trial GRID (GIST – Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506), a Bayer-owned compound, for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The trial met its primary endpoint of statistically significant improvement in progression-free survival.  In this trial, the safety and tolerability of regorafenib were consistent with what was seen in earlier studies. Data from the study are expected to be presented at an upcoming scientific meeting. The GRID study was sponsored by Bayer with academic leadership from the principal investigator George Demetri, M.D., Director of the Ludwig Center at the Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, U.S.A. The study started in January 2011 and completed enrollment by July 2011. 

"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, M.D., Executive Vice President, Research and Development and Technical Operations at Onyx Pharmaceuticals. "These clinical data will show regorafenib's activity in patients with previously treated GIST."