IO Biotech(US:IOBT) Globenewswire·2025-10-20 06:30Core Insights - IO Biotech presented detailed results from its global Phase 3 trial of Cylembio in combination with Merck's KEYTRUDA for treating advanced melanoma, showing promising progression-free survival outcomes [1][3][12] Phase 3 Trial Results - The Phase 3 trial involved 407 patients with untreated advanced melanoma, comparing Cylembio plus pembrolizumab to pembrolizumab alone, achieving a median progression-free survival (mPFS) of 19.4 months versus 11.0 months for pembrolizumab alone [3][12] - The combination narrowly missed the primary endpoint for statistical significance with a p-value of 0.0558 [3][8] - Subgroup analyses indicated improved outcomes for the combination therapy across various patient categories, including those with PD-L1-negative tumors and BRAFV600 mutations [4][8] Safety and Tolerability - The combination therapy was well tolerated, showing no significant increase in immune-mediated adverse events or grade ≥3 treatment-related events compared to pembrolizumab alone [5][9] - Local vaccine-related injection-site reactions were mild and transient, primarily grade 1/2 [5] Phase 2 Basket Trial Results - Final results from the Phase 2 basket trial evaluating Cylembio with pembrolizumab in advanced non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN) were also presented, showing a median progression-free survival of 8.1 months for NSCLC and 7.0 months for SCCHN [2][9][13] - The safety profile in the Phase 2 trial remained consistent with anti-PD-1 monotherapy, with no new safety signals reported [9] Company Overview - IO Biotech is focused on developing immune-modulatory, off-the-shelf therapeutic cancer vaccines, with Cylembio being its lead candidate currently in pivotal clinical trials [10][14] - The company maintains global commercial rights to Cylembio and is collaborating with Merck for the supply of pembrolizumab in its clinical trials [11][14]