ARTICLE | Clinical News

PLX4032: Phase II data

November 8, 2010 8:00 AM UTC

The single-arm, open-label, U.S. and Australian Phase II BRIM2 trial in 132 patients with previously-treated BRAF V600E mutation-positive metastatic melanoma showed that twice-daily 960 mg oral RG7204 produced an ORR of 52%, which Roche said met the primary endpoint by exceeding a pre-defined ORR threshold of 30%. RG7204 produced 66 partial responses and 39 cases of stable disease. Median duration of response was 6.8 months and median PFS was 6.2 months. Roche said the historical PFS for melanoma patients with the BRAF V600E mutation is about 2 months. Median OS has not yet been reached. ...