Regorafenib: Additional Phase III data

Additional data from the double-blind, international Phase III GRID trial in 199 patients showed that oral regorafenib plus best supportive care (BSC) led to median PFS, the primary endpoint, of 4.8 months vs. 0.9 months for placebo plus BSC (HR=0.27, p<0.0001). The most common adverse events were hand-foot skin reactions, hypertension, diarrhea, fatigue, oral mucositis, alopecia, hoarseness, anorexia, myalgia, maculopapular rash, nausea, constipation and voice alteration. The trial enrolled patients with metastatic and/or unresectable GIST whose disease had progressed despite prior treatment with at least imatinib and sunitinib to receive placebo or once-daily 160 mg oral regorafenib for the first 3 weeks of a 4-week cycle, plus best supportive care (BSC). Patients who received placebo were eligible to receive regorafenib following disease progression. BSC excluded any disease-specific anti-cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy or surgery. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...