FDA Approval Insights: Atezolizumab Plus Cobimetinib and Vemurafenib in BRAF V600+ Advanced Melanoma

Welcome to a very special edition of OncLive^® On Air! I’m your host today, Caroline Seymour.

OncLive^® On Air is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

Today, we had the pleasure of speaking with Omid Hamid, MD, director of the Melanoma Center and Phase I Immuno-Oncology Program at The Angeles Clinic and Research Institute, to discuss the FDA approval of atezolizumab (Tecentriq) in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) in BRAF V600 mutation–positive advanced melanoma.

The July 30, 2020 regulatory decision was based on data from the pivotal phase 3 IMspire150 trial, in which the addition of atezolizumab to cobimetinib and vemurafenib led to a significant improvement in progression-free survival (PFS) versus placebo plus cobimetinib/vemurafenib in treatment-naïve patients with BRAF V600–mutant advanced melanoma.

The results from the trial, which were presented during the 2020 AACR Annual Virtual Meeting I, showed that the triplet led to a median PFS of 15.1 months versus 10.6 months with vemurafenib/cobimetinib, translating to a 22% reduction in the risk of progression or death with the triplet. Additionally, this benefit was reported across all prognostic subgroups that were analyzed. The median PFS, when assessed by independent review committee, was 16.1 months versus 12.3 months with the triplet and the doublet, respectively.

The objective response rates were comparable between the 2 treatment arms; however, patients who received the triplet experienced a prolonged median duration of response of 21.0 months versus 12.6 months with the doublet.

In our exclusive interview, Hamid contextualized the FDA approval of atezolizumab in combination with cobimetinib and vemurafenib in BRAF V600 mutation–positive advanced melanoma and discussed important takeaways from the IMspire150 trial.