Vemurafenib, a ‘BRAF-inhibitor,’ is designed to selectively target and inhibit a mutated form of the BRAF protein, a component of the RAS-RAF pathway involved in normal cell growth and survival.
The submissions are based on results from two positive clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma, as determined by the investigational companion diagnostic test also being developed by Roche.
BRIM3 is an open-label, controlled, multicenter, Phase III study that compared vemurafenib to dacarbazine chemotherapy in 675 patients with previously untreated BRAF V600 mutation-positive, unresected or locally advanced metastatic melanoma.
The study met its co-primary endpoints and showed that participants who received vemurafenib lived longer (overall survival) and also lived longer without their disease getting worse (progression-free survival or PFS) compared to those who received dacarbazine chemotherapy.
BRIM2 is a multicenter, open-label Phase II study that enrolled 132 patients with previously treated BRAF V600 mutation-positive metastatic melanoma.
People who participated in the trial lived a median of 6.2 months without their disease getting worse (median PFS).
Roche has also submitted a marketing authorization application to the European Medicines Agency (EMA) for vemurafenib in the same indication.
Under a collaboration agreement between Roche/Genentech and Plexxikon vemurafenib is being co-developed.