Final overall survival for KEYNOTE-002: pembrolizumab (pembro) versus investigator-choice chemotherapy (chemo) for ipilimumab (ipi)-refractory melanoma

Abstract

Background: In KEYNOTE-002 (NCT01704287), pembro provided superior PFS over investigator-choice chemo in patients (pts) with advanced melanoma and confirmed progression after ≥2 ipi doses (HR 0.57, P <1% for chemo. ORR was 22%, 28%, and 4%; 73%, 74%, and 13% of responders had no progression at analysis. Grade 3-5 drug-related AE rates remained lower with pembro (13% and 17% vs 26%) despite longer exposure (mean 232 d and 276 d vs 82 d). Conclusions: Pembro prolonged OS over chemo for ipi-refractory melanoma; with a 55% crossover rate, the difference did not reach statistical significance for either pembro dose. Coupled with the significant PFS benefit, durable responses, and lower rate of high-grade drug-related AEs, these data support pembro as a standard of care for this population.