RG7204 meets melanoma endpoint

Plexxikon Inc. (Berkeley, Calif.) and partner Roche (SIX:ROG; OTCQX:RHHBY) said RG7204 ( PLX4032) met the primary endpoint of overall response rate (ORR) in the Phase II BRIM2 trial in 132 patients with previously-treated BRAF V600E mutation-positive metastatic melanoma. Twice-daily oral RG7204 produced an ORR of 52%, which Roche said exceeded the endpoint's 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 overall survival has not yet been reached. Thirty-four patients developed cutaneous squamous cell carcinomas (SCC) that were managed by local excision. ...