Hal Barron M.D., Chief Medical Officer and Head, Global Product Development said, For the first time, a personalized investigational medicine, RG7204, has shown a significant survival benefit in metastatic melanoma. This is an important advance for people with the BRAF V600 mutation-positive form of the disease who have had extremely limited treatment options.
Based on these interim analysis results, patients on the control arm of the study will have the option to crossover to receive RG7204.
Roche is now working closely with global health authorities to expand the recently announced RG7204 Early Access Program (EAP). The global EAP will be extended to include people with previously untreated, BRAF V600 mutation-positive metastatic melanoma (first line).
RG7204 exemplifies Roche’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 Testfrom Roche Molecular Diagnostics to identify patients whose tumors carry the mutated BRAF V600 gene.
BRIM3 (Study NO25026) is a global, randomized, open-label, controlled, multicenter, Phase III study evaluating RG7204 compared to dacarbazine (the current chemotherapy standard of care) in patients with previously untreated, BRAF V600 mutation-positive metastatic melanoma. Mutation status of the 675 enrolled patients was determined by the cobas 4800 BRAF V600 Mutation Test (Roche Molecular Diagnostics) a companion diagnostic assay being co-developed with RG7204.
Study participants were randomized to receive either RG7204 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Patients continued dosing until their disease progressed or there was unacceptable toxicity.
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.
The BRIM3 study started in Q1 2010 and was carried out at over 100 sites worldwide including the US, UK, France, Germany, Australia, New Zealand, Italy and Spain.