On 30 July 2020, the US Food and Drug Administration (FDA) 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, randomised (1:1), placebo-controlled, multicentre 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 v1.1. Median PFS was 15.1 months (95% confidence interval [CI] 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 = 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, oedema, 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.
Full prescribing information for TECENTRIQ is available here.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks ahead of the FDA goal date.
The FDA collaborated with Switzerland’s Swissmedic on the review of this application as part of Project Orbis.
This application was granted priority review and atezolizumab was granted orphan product designation.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.