The Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab; Genentech) in combination with cobimetinib (Cotellic®; Genentech) and vemurafenib (Zelboraf®; Genentech) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 IMspire150 study that evaluated the efficacy and safety of atezolizumab, a programmed death-ligand 1 (PD-L1) blocking antibody, plus cobimetinib and vemurafenib in 514 adult patients with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. After a 28-day treatment cycle of cobimetinib and vemurafenib, patients received atezolizumab 840mg intravenous infusion every 2 weeks in combination with cobimetinib 60mg orally once daily and vemurafenib 720mg orally twice daily, or placebo in combination with cobimetinib 60mg orally once daily and vemurafenib 960mg orally twice daily.
The primary end point was investigator-assessed progression-free survival (PFS) as per RECIST v1.1. Results showed a statistically significant improvement in PFS in the atezolizumab treatment arm compared with the placebo arm (median PFS: 15.1 months vs 10.6 months, respectively; hazard ratio [HR] 0.78; 95% CI, 0.63-0.97; P =.025).
Regarding safety, the most common adverse reactions (≥20%) in patients treated with atezolizumab plus cobimetinib and vemurafenib were rash (75%), musculoskeletal pain (62%), fatigue (51%), hepatotoxicity (50%), pyrexia (49%), nausea (30%), pruritus (26%), edema (26%), stomatitis (23%), hypothyroidism (22%), and photosensitivity reaction (21%).
“When receiving a cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than 15 months without their disease worsening,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Today’s FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”
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1. FDA approves Genentech’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma. https://www.businesswire.com/news/home/20200730006043/en/FDA-Approves-Genentech%E2%80%99s-Tecentriq-Cotellic-Zelboraf-People. Accessed July 31, 2020.
2. Tecentriq [package insert]. South San Francisco, CA: Genentech; 2020.