FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma
On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
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).
The most common adverse reactions (≥ 20%) with atezolizumab in combination with cobimetinib and vemurafenib in patients with melanoma were rash, musculoskeletal pain, nausea, fatigue, hepatotoxicity, pyrexia, nausea pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.
The recommended atezolizumab dose, following completion of a 28-day cycle of cobimetinib and vemurafenib, is 840 mg every 2 weeks with cobimetinib 60 mg orally once daily (21 days on /7 days off) and vemurafenib 720 mg orally twice daily.
View full prescribing information for TECENTRIQ.