Five-year follow-up of a multinational randomized phase 2 trial of ipilimumab with or without T-VEC for advanced melanoma

A multinational randomized phase 2 trial compared talimogene laherparepvec (T-VEC) plus ipilimumab versus ipilimumab monotherapy for previously untreated, unresectable, stage IIIB-IV melanoma. Five-year follow-up results of the trial showed that the combination improved the objective response rate versus ipilimumab (35.7% versus 16.0%; OR 2.9; p=0.003) while the durable response rate was 33.7% versus 13.0% (unadjusted OR 3.4; descriptive p=0.001). Among the objective responders, the median duration of response was 69.2 months with the combination and was not reached with ipilimumab. No new safety signals were reported.