Clear clinical benefit with cobimetinib added to vemurafenib in advanced BRAFV600-mutant melanoma

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  • Cobimetinib combined with vemurafenib as a first-line approach improved survival outcomes in patients with advanced BRAFV600-mutant melanoma.
Study design
  • Phase 3 randomized multicenter study that evaluated the efficacy and safety of a combination of cobimetinib and vemurafenib vs placebo and vemurafenib in 495 previously untreated patients with BRAFV600 mutation-positive unresectable stage IIIC or stage IV melanoma.
  • Funding: The study was funded by F Hoffmann-La Roche–Genentech.
Key results
  • Median OS for the cobimetinib and vemurafenib group was 22.3 mo (95% CI, 20.3 mo-not estimable) vs 17.4 mo (95% CI, 15.0-19.8 mo) for vemurafenib/placebo (HR, 0.70; 95% CI, 0.55-0.90; P=.005).
  • 1-y OS was 74.5% (95% CI, 68.9%-80.2%) for the cobimetinib/vemurafenib group and 63.8% (95% CI, 57.6%-70.0%) for vemurafenib/placebo.
  • Med...