FDA Approves Combination Therapy for Treating Advanced Melanoma


Officials with the FDA have approved atezolizumab plus cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

Officials with the FDA have approved atezolizumab (Tecentriq®, Genentech) plus cobimetinib (Cotellic®, Genentech and Exelixis) and vemurafenib (Zelboraf®, Genentech and Daiichi Sankyo) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma. The safety profile observed in the atezolizumab combination was consistent with the known safety profiles of the individual medicines, according to Genentech.

Atezolizumab is a prescription monoclonal antibody designed to bind with a protein, PD-L1, expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. The therapy is currently utilized for treatment of patients with certain types of cancer, including urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, and hepatocellular carcinoma.

The approval of the atezolizumab combination for BRAF V600 mutation-positive advanced melanoma is based on results from the Phase III IMspire150 study, a multi-center, double-blind, placebo-controlled randomized study in individuals with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study results showed the addition of atezolizumab to cobimetinib and vemurafenib helped individuals live longer without their disease worsening or death (progression-free survival, PFS), compared to placebo plus cobimetinib and vemurafenib (median PFS 15.1 months versus 10.6 months respectively; hazard ratio, HR=0.78; confidence interval: 0.63-0.97; P=0.025).

The most common adverse reactions (rate ≥20%) in patients who received atezolizumab with 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 or atezolizumab was granted under Priority Review. The review was also conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners.

According to Genentech, the company has an extensive development program for atezolizumab, including multiple ongoing and planned phase 3 studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating atezolizumab both alone and in combination with other medicines.

For those who qualify, Genentech will offer patient assistance programs for patients prescribed atezolizumab with cobimetinib and vemurafenib by their doctor through Genentech Access Solutions.


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

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