Journal of Clinical OncologyRandomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined with Pembrolizumab for Advanced Melanoma

Resistance to immune checkpoint inhibitors is common. In a prior phase Ib study, the combination of talimogene laherparepvec (T-VEC) pembrolizumab demonstrated an encouraging complete response rate and acceptable safety profile in patients with advanced melanoma. In this phase III, randomized, double-blind, multicenter, international study, the combination of T-VEC-pembrolizumab did not statistically improve PFS or OS vs placebo-pembrolizumab. However, T-VEC-pembrolizumab demonstrated a numerical PFS improvement without new safety signals.