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FDA Approves Atezolizumab Combo for BRAF V600+ Melanoma
On July 30, 2020, the FDA granted approval to atezolizumab (Tecentriq; Genentech) combined with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This application was granted priority review and atezolizumab was granted orphan product designation by the FDA.
This approval was based on efficacy data from the double-blind, placebo-controlled, multi-center IMspire150 clinical trial. In this study, 514 patients were randomized in a 1:1 ratio to receive atezolizumab 840 mg every 2 weeks in combination with cobimetinib 60 mg once daily and vemurafenib 720 mg twice daily or placebo in combination with cobimetinib and vemurafenib after a 28-day cycle of cobimetinib plus vemurafenib.
The main efficacy end point was investigator-assessed progression-free survival (PFS) per RECIST 1.1.
Findings showed a median PFS of 15.1 months (95% CIm 11.4-18.4) in the atezolizumab arm and 10.6 months (95% CI, 9.3-12.7) in the placebo arm (hazard ratio, 0.78; 95% CI, 0.63-0.97; P = .0249).
The most frequently reported (≥20%) adverse reactions with the combination regimen were rash, musculoskeletal pain, nausea, fatigue, hepatotoxicity, pyrexia, nausea pruritus, edema, stomatitis, hypothyroidism, and photosensitivity reaction.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma. Updated July 31, 2020. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-atezolizumab-braf-v600-unresectable-or-metastatic-melanoma. Accessed August 3, 2020.
