IO Biotech says statistical significant missed on primary endpoint for Cylembio

IO Biotech (IOBT) announces topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio. The trial evaluated Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic melanoma. In the study, Cylembio plus pembrolizumab demonstrated clinical improvement in progression free survival compared to pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint. The combination was well tolerated, with no new safety signals observed. Injection site reactions, which were transient and resolved on treatment, were the most commonly reported adverse events in the combination arm, with 56% of patients receiving Cylembio plus pembrolizumab reporting an event.