Core Insights - IO Biotech announced topline results from the pivotal Phase 3 trial of its investigational cancer vaccine Cylembio, showing clinical improvement in progression-free survival (PFS) when combined with Merck's KEYTRUDA compared to KEYTRUDA alone [1][2][5] Study Results - The trial involved 407 patients with unresectable or metastatic melanoma, with 203 receiving Cylembio plus KEYTRUDA and 204 receiving KEYTRUDA alone [2][8] - The primary endpoint of PFS showed a hazard ratio of 0.77, with a median PFS of 19.4 months for the combination group versus 11.0 months for the control group [2][5] - A trend towards improved overall survival (OS) was observed, with a hazard ratio of 0.79, although OS data is not yet mature [2][5] Subgroup Analysis - Improvement in PFS was noted across nearly all subgroups, particularly in patients with PD-L1 negative tumors, achieving a median PFS of 16.6 months compared to 3.0 months for the control group [3][5] - In patients without prior anti-PD-1 treatment, the combination therapy resulted in a median PFS of 24.8 months versus 11.0 months for the control group [3][5] Safety and Tolerability - The combination therapy was well tolerated, with no new safety signals reported; the most common adverse events were transient injection site reactions, reported by 56% of patients in the combination arm [4][5] Future Plans - IO Biotech plans to engage with the FDA to discuss the data and potential regulatory submission for Cylembio [2][6][12] - The company will present more detailed results at an upcoming medical meeting [6][12]

Cylembio (IO102-IO103) Development and Clinical Trials - Cylembio, in combination with pembrolizumab, has Breakthrough Therapy Designation for advanced melanoma[11, 12] - Phase 3 pivotal trial in advanced melanoma with PFS as the primary endpoint, readout expected in Q3 2025[12, 23, 27] - Phase 1/2 trial (MM1636) showed 80% ORR, 50% CRR, and 255 months mPFS in melanoma[13, 55] - Completed enrollment of 407 patients in the Phase 3 trial in December 2023[27, 55] - A Phase 2 neoadjuvant/adjuvant basket study is fully enrolled[57] Pipeline and Platform - T-win platform delivers investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccines[11, 35, 66] - The company has 3 pipeline programs, including IO170 targeting Melanoma, SCCHN, NSCLC, and other cancers[11, 35] - IO112, targeting Arginase 1, is a next pipeline candidate expected to enter clinical development, with an IND filing planned in 2025[35, 63, 64] Market and Financial Outlook - The global melanoma market is expected to reach >$13 billion by 2030[15] - The US melanoma market was approximately $45 billion in 2023, growing at 9%[32] - The global NSCLC market is expected to reach approximately $60 billion by 2030[36, 37] - The global SCCHN market is expected to reach approximately $5 billion by 2030[40]