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.