Cobimetinib improves overall survival (OS), in addition to progression-free survival (PFS), of patients with advanced, unresectable BRAFV600-mutant melanoma, according to a study published in The Lancet Oncology.1
In this article, the authors report the updated results of a double-blind, randomized, phase 3 study, in which patients were assigned to receive either cobimetinib with vemurafenib or vemurafenib with placebo.
Of 495 enrolled patients, 247 were assigned to the cobimetinib group and 248 were assigned to placebo; final OS analyses occurred when 52% of all enrolled patients died. Median OS was 22.3 months (95% CI 20·3–not estimable) in the cobimetinib group and 17.4 months (95% CI 15·0–19·8) for those in the placebo group.
The authors conclude that these updated efficacy results confirm the clinical benefit of cobimetinib in conjunction with vemurafenib, and that the combination ought to be used as a standard first-line therapy. Some grade 3-4 adverse events occurred more frequently in the cobimetinib group, including γ-glutamyl transferase increase (15% of patients receiving cobimetinib), blood creatine phosphokinase increase (12%), and alanine transaminase increase (11%).
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Serious adverse events occurred for 92 patients in the cobimetinib group and included pyrexia (2% of patients) and dehydration (2%).
- Ascierto PA, McArthur GA, Dreno B. Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 29 Jul 2016. doi: 10.1016/S1470-2045(16)30122-X [Epub ahead of print]