On July 30, 2020, the FDA approved atezolizumab (Tecentriq, Genentech) in combination with cobimetinib and vemurafenib for BRAF V600-mutated unresectable or metastatic melanoma.
This approval is based on results from the double-blind, randomized, placebo-controlled, multicenter IMspire150 trial, which enrolled 514 patients with BRAF V600-mutated unresectable or metastatic melanoma.
After a 28-day cycle of cobimetinib, patients were randomized in a 1:1 ratio to receive either atezolizumab 840 mg IV 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 main outcome measure was progression-free survival (PFS) as assessed by investigators per RECIST 1.1.
Median PFS was 15.1 months (95% CI: 11.4, 18.4) in the atezolizumab arm versus 10.6 months (95% CI: 9.3, 12.7) in the placebo arm (HR 0.78; 95% CI: 0.63, 0.97; P = .0249).
The most common adverse events with the triplet combination, occurring in ≥20% of patients, were rash, musculoskeletal pain, nausea, fatigue, hepatotoxicity, pyrexia, nausea pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.—Janelle Bradley
Source: US Food and Drug Administration. FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma. July 30, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-braf-v600-unresectable-or-metastatic-melanoma. Accessed July 31, 2020.
