Three-year estimate of overall survival in COMBI-v, a randomized phase 3 study evaluating first-line dabrafenib (D) + trametinib (T) in patients (pts) with unresectable or metastatic BRAF V600E/K–mutant cutaneous melanoma

Abstract

Background: Prior comparative analyses of COMBI-v (NCT01597908) at a planned interim cutoff and again after 2 y of follow-up (f/u) showed significantly improved outcomes favoring D + T vs vemurafenib (Vem). Durable benefit and sustained tolerability was also seen in some pts receiving D + T (COMBI-v: 2-y OS, 51%; COMBI-d: 2-y OS, 52%; 3-y OS, 44%). Although these results support use of first-line D + T for BRAF V600–mutant melanoma, continued monitoring of these pts for long-term efficacy (eg, OS) is needed to determine the full impact of this regimen.