Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.
The most frequent Grade 3 adverse events were skin related and included cutaneous squamous cell carcinoma, a common skin cancer treated by local excision. Additionally, generally mild and reversible increases in liver enzymes (GGT, ALT, AST, alkaline phosphatase, and bilirubin) were observed in some patients. The most common adverse events were rash, photosensitivity, joint pain, hair loss and fatigue.
Full data will be presented at a medical meeting later this year.
Genentech is now working closely with global health authorities to expand the recently announced RG7204 Patient Access Program (PAP). The PAP will be extended to include people with previously untreated, BRAF V600 mutation-positive metastatic melanoma (first line).
RG7204 exemplifies Genentech’s personalized healthcare approach using biomarkers and diagnostic tools to identify the right medicine for the right patient. RG7204 is being co-developed with an investigational diagnostic test, the cobas?® 4800 BRAF V600 Mutation Test from Roche Molecular Diagnostics, to identify patients whose tumors carry the mutated BRAF V600 gene.