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Breaking Boundaries: IO Biotech's Cylembio Phase 3 Results Unveiled

IO Biotech (IOBT) | November 2025

By Alice Johnson

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IO Biotech presented promising Phase 3 results for its investigational drug candidate, Cylembio.

The study demonstrated clinical improvement with narrow misses on statistical significance, indicating potential broad application.

The platform shows improved clinical effects without significant added systemic toxicity, positioning Cylembio as an ideal combination partner.

Statistical Significance

The study's statistical significance threshold was set at p≥0.045, showcasing the drug's efficacy.

Clinical Improvement

Cylembio demonstrated a progression-free survival (PFS) improvement across various subgroups and stratification factors.

Market Opportunity

With a growing $5.6 billion US market opportunity and plans for phase 3 design alignment with FDA, Cylembio holds substantial potential.

  • Cylembio presents a significant opportunity for clinical advancement across multiple indications, including Melanoma, SCCHN, and NSCLC.
  • The drug's pipeline may address challenging-to-treat cancers, offering hope for patients seeking novel treatment combinations.

IO Biotech's Cylembio Phase 3 results mark a pivotal moment in the fight against cancer, setting the stage for further advancements and potential regulatory submissions in 2025.