IO Biotech’s off-the-shelf cancer vaccine Cylembio in combination with Merck’s Keytruda demonstrated encouraging but narrowly missed statistically significant improvement in progression-free survival for unresectable or metastatic melanoma patients in a Phase 3 trial. Post-hoc analyses suggest stronger benefits in treatment-naive subgroups. Despite the primary endpoint miss, the company aims to seek FDA approval based on the totality of data, citing favorable safety and promising overall survival trends.