Addition of First-Line Atezolizumab to Vemurafenib/Cobimetinib in BRAF V600–Mutant Advanced Melanoma
Source: The ASCO Post, December 2022
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, and colleagues, the second interim overall survival analysis of the phase III IMspire150 trial has shown a numeric but statistically nonsignificant improvement with the addition of first-line atezolizumab to vemurafenib and cobimetinib in patients with BRAF V600–mutant advanced melanoma.
The previously reported primary analysis of the trial, which showed a significant improvement in investigator-assessed progression-free survival with the addition of atezolizumab (median follow-up = 18.9 months) supported the July 2020 approval of atezolizumab plus vemurafenib/cobimetinib in this setting.
Study Details
The double-blind trial included 514 patients with unresectable stage IIIC or stage IV disease from sites in 20 countries. Patients were randomly assigned between January 2017 and April 2018 to receive atezolizumab at 840 mg (n = 256) or placebo (n = 258) on days 1 and 15 plus vemurafenib at 960 mg or 720 mg twice daily and cobimetinib at 60 mg once daily for 21 days on and 7 days off in 28-day cycles. Atezolizumab and placebo were added to treatment at cycle 2. Overall survival was assessed in the intention-to-treat population, with the interim analysis planned after approximately 270 events had occurred.