Phase 3 Trial Update of Regorafenib for Metastatic Gastrointestinal Stromal Tumors

Bayer HealthCare today announced results from its Phase 3 trial GRID (GIST – Regorafenib in Progressive Disease) evaluating its investigational compound regorafenib (BAY 73-4506) 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 (Gleevec; Novartis Pharmaceuticals Corp) and sunitinib (Sutent; Pfizer Inc).

GRID (GIST – Regorafenib In Progressive Disease) was a randomized, double-blind, placebo-controlled, multi-center, cross-over Phase 3 study of regorafenib for the treatment of GIST. It enrolled 199 patients whose disease had progressed despite prior treatment with at least imatinib and sunitinib. Patients were randomized in a 2:1 ratio to receive either regorafenib (160mg once daily, 3 weeks on/1 week off) plus best supportive care (BSC) or placebo plus BSC. Subjects receiving placebo who experienced disease progression were offered regorafenib treatment. The primary endpoint of this trial is progression-free survival, and secondary endpoints include overall survival, time to progression, disease control rate, tumor response rate, and duration of response. In this trial, safety was also evaluated.

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.

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

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