RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204 (PLX4032), met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma. Study participants who received RG7204 lived longer (overall survival) and also lived longer without their disease getting worse (progression-free survival) compared to participants who received dacarbazine, the current standard of care. RG7204 is a potential first-in-class medicine designed to selectively inhibit the mutated BRAF protein found in about half of all cases of metastatic melanoma - the most aggressive and deadliest form of skin cancer. The safety profile was generally consistent with previous RG7204 studies.

"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," said Hal Barron M.D., chief medical officer and head, Global Product Development.

Based on these interim analysis results, patients on the control arm of the study will have the option to crossover to receive RG7204.

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.