Genentech has reported that a Phase III clinical study of RG7204 (PLX4032) has met its co-primary endpoints, demonstrating a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.
The study results showed that RG7204 improved overall survival and progression-free survival in patients when compared to dacarbasine, the current chemotherapy standard of care.
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The global, randomised, open-label, controlled and multicentre study was designed to evaluate RG7204 compared to dacarbasine in patients with previously untreated, BRAF V600 mutation-positive metastatic melanoma.
Patients were randomised to receive either RG7204 960mg orally twice a day or dacarbasine 1000mg/m² intravenously every three weeks.
The study was initiated in Q1 2010 and was conducted at more than 100 sites across the world.
RG7204 is an investigational, oral, small molecule that is designed to selectively inhibit a mutated form of the BRAF protein. It is being developed under a collaboration between Genentech, Roche and Plexxikon.
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