Date: 2011-01-19
Type of information:
phase: 3
Announcement: results of a phase 3 study
Company: Roche (Switzerland)
Product: RG7204 The product is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon.
Action mechanism: This investigational, oral, small molecule has been esigned to selectively inhibit a cancer-causing mutated form of the BRAF protein. A polymerase chain reaction-based companion diagnostic, the cobas 4800 BRAF V600 Mutation Test, is being co-developed by Roche Molecular Diagnostics and Plexxikon in parallel to identify people whose tumors carry the BRAF V600 mutation.
Disease: BRAF V600 mutation-positive metastatic melanoma.
Therapeutic area: CancerOncology
Country: US, UK, France, Germany, Australia, New Zealand, Italy and Spain.
Trial
details: 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 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.
Latest
news: BRIM3 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. The safety profile was generally consistent with previous RG7204 studies. Based on these interim analysis results, patients on the control arm of the study will have the option to crossover to receive RG7204. Full data will be presented at a medical meeting later this year.
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).
