Phase III GRID study of BAY 73-4506 (Bayer HealthCare) for GIST meets primary endpoint

The Phase III GRID trial evaluating BAY 73-4506 (regorafenib), from Bayer HealthCare, in patients with metastatic and/or unresectable Gastrointestinal Stromal Tumors (GIST) met its primary endpoint. The median PFS was 4.8 months in the BAY 73-4506 arm versus 0.9 months in the placebo arm. The most common adverse events included hand-foot skin reaction (56.1% vs.15.2%), hypertension (48.5% vs. 16.7%) and diarrhea (40.9% vs.7.6%). The data was presented at the Annual Meeting of the American Society of Clinical Oncology. Bayer plans to submit a New Drug Application for regorafenib in GIST in the second half of 2012.