Tecentriq (atezolizumab) received FDA approval in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Tecentriq is sponsored by Genentech Inc.
Efficacy in combination with cobimetinib and vemurafenib was evaluated in a double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150, NCT02908672) in 514 patients. After a 28-day cycle of cobimetinib and vemurafenib, patients received atezolizumab 840 mg intravenous infusion every 2 weeks in combination with cobimetinib 60 mg orally once daily and vemurafenib 720 mg orally twice daily, or placebo in combination with cobimetinib 60 mg orally once daily (21 days on/7 days off) and vemurafenib 960 mg orally twice daily.
The primary efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST 1.1. Median PFS was 15.1 months (95% CI: 11.4, 18.4) in the atezolizumab arm and 10.6 months (95% CI: 9.3, 12.7) in the placebo arm (HR 0.78; 95% CI: 0.63, 0.97; p=0.0249).
This application was granted priority review and atezolizumab was granted orphan product designation. FDA collaborated with Switzerland’s Swissmedic on the review of this application as part of Project Orbis.