FDA Approves Atezolizumab Plus Cobimetinib and Vemurafenib for Advanced Melanoma

The FDA has approved atezolizumab (Tecentriq) plus cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma, according to Genentech, atezolizumab’s developer.

The approval was based on results from the multi-center, double-blind, placebo-controlled, randomized, phase 3 IMspire150 study, which evaluated individuals with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of atezolizumab plus cobimetinib and vemurafenib to the combination of placebo plus cobimetinib and vemurafenib.

The primary end point of the study was investigator-assessed progression-free survival (PFS). Key secondary end points included PFS by an independent review committee, overall survival (OS), objective response rate, duration of response, and other safety and pharmacokinetic measures.

Overall, the addition of atezolizumab to cobimetinib and vemurafenib led to a longer PFS, compared to placebo plus cobimetinib and vemurafenib (median PFS, 15.1 months vs 10.6 months, respectively; HR, 0.78; 95% CI, 0.63-0.97; P = 0.025).

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “Today’s FDA approval of this [atezolizumab] combination represents an important step forward for many patients living with advanced melanoma.”

The safety profile observed in the atezolizumab combination was consistent with the known safety profiles of the individual medicines. The most common adverse events (AEs; rate ≥20%) observed in patients who received 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%).

The supplemental Biologics License Application (sBLA) for atezolizumab was granted under priority review. Moreover, the review was also conducted under the FDA’s Project Orbis.

Reference:

FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma [news release]. South San Francisco, CA. Published July 30, 2020. gene.com/media/press-releases/14868/2020-07-30/fda-approves-genentechs-tecentriq-plus-c. Approved July 30, 2020.