Roche reported Wednesday that its new skin-cancer drug RG7204 helps patients with advanced forms of the disease live longer and without their illness worsening in a late-stage clinical study.
The Phase III clinical study BRIM3 of RG7204 met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma. Patients receiving 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,” said Roche chief medical officer Hal Barron,”This is an important advance for people with the BRAF V600 mutation-positive form of the disease who have had extremely limited treatment options.”
Advanced melanoma is one of the deadliest cancer forms and kills more than 40,000 people every year. According to a Datamonitor report, the number of people with melanoma in developed countries is predicted to double over the next decade to around 227,000 new cases every year. This is despite government efforts to raise awareness of the condition by discouraging people from spending long periods in the sun and promoting the use of sunscreen.
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 Test from Roche Molecular Diagnostics, to identify patients whose tumors carry the mutated BRAF V600 gene.
Roche said the RG7204 trial data were very strong and underscored that its efforts to boost personalized medicine are paying off.