IO Biotech's Skin Cancer Vaccine Combo Falls Short of Expectations, Seeks FDA Approval

IO Biotech's investigational cancer vaccine, Cylembio, demonstrated clinical improvement in progression-free survival when combined with Merck's Keytruda for unresectable or metastatic melanoma. However, statistical significance was narrowly missed on the primary endpoint. The company plans to meet with the FDA this fall to discuss the data and determine next steps for a Biologics License Application. IO Biotech stock is trading lower by 10.5% to $1.621.

IO Biotech, a clinical-stage biopharmaceutical company, has announced promising results from its pivotal Phase 3 trial of Cylembio, an investigational cancer vaccine, in combination with Merck's Keytruda (pembrolizumab) for the treatment of first-line advanced melanoma. The trial demonstrated clinical improvement in progression-free survival (PFS) compared to Keytruda monotherapy, though it narrowly missed statistical significance on the primary endpoint [1][2].

Patients treated with the combination therapy achieved a median PFS of 19.4 months versus 11.0 months for those on Keytruda alone, with a hazard ratio of 0.77. Notably, the combination therapy showed a median PFS of 16.6 months in patients with PD-L1 negative tumors, compared to just 3.0 months with Keytruda alone [3]. The combination was well-tolerated with no new safety concerns identified.

IO Biotech plans to meet with the FDA this fall to discuss the data and determine next steps for a Biologics License Application. While overall survival data is not yet mature, early trends show improvement favoring the combination therapy across multiple patient subgroups. The company intends to present more detailed results from the study at an upcoming medical meeting.

IO Biotech stock is trading lower by 10.5% to $1.621 following the announcement [3].

References:

[1] https://www.marketscreener.com/news/io-biotech-announces-clinical-improvement-in-progression-free-survival-demonstrated-in-pivotal-phase-ce7c5ed2de8ef727
[2] https://www.biospace.com/press-releases/io-biotech-to-announce-topline-results-of-pivotal-phase-3-trial-of-cylembio-in-combination-with-keytruda-pembrolizumab-as-a-first-line-treatment-for-patients-with-advanced-melanoma
[3] https://www.investing.com/news/stock-market-news/io-biotech-stock-rises-as-cancer-vaccine-shows-promising-results-93CH-4183078