Masitinib: Phase II data

An open-label, French Phase II trial in 44 patients with inoperable, locally advanced or metastatic GIST whose disease progressed following treatment with Gleevec imatinib showed that 12 mg/kg/day oral masitinib significantly improved median OS, a secondary endpoint, vs. Sutent sunitinib at a median follow-up of 14 months. Specifically, median OS for patients receiving Sutent was 15 months, while median OS for masitinib has not yet been reached (p=0.022). Additionally, 79% and 53% of patients receiving masitinib were alive at 18 and 24 months, respectively, vs. 20% and 0% for Sutent. Masitinib also had a lower occurrence of severe adverse events vs. Sutent. The most common masitinib-related adverse events were nausea, diarrhea and asthenia. Full data will be submitted for presentation at the American Society of Clinical Oncology meeting in Chicago in June. ...