Phase 3 Trial Update of Regorafenib for Gastrointestinal Stromal Tumors (GIST)

Bayer HealthCare announced data from GRID, a cross-over Phase 3 study of regorafenib for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib. The median progression-free survival was 4.8 months in the regorafenib arm vs. 0.9 months in the placebo arm.

GRID (GIST – Regorafenib In Progressive Disease) was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase 3 study of regorafenib in 199 patients whose disease had progressed despite prior treatment with imatinib and sunitinib. The GRID study met its primary endpoint of improvement in PFS (HR=0.27, p<0.0001).

Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

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