other material
confidence high
sentiment neutral
materiality 0.65
IO Biotech Phase 3 trial IDMC recommends continuation; PFS endpoint expected H1 2025
IO Biotech, Inc.
- IDMC recommends Phase 3 trial of IO102-IO103 + pembrolizumab continue without modifications after interim analysis.
- Interim ORR analysis did not meet pre-specified high statistical bar (p≤0.005); most alpha preserved for PFS.
- Primary endpoint PFS event-driven at 226 events; trial 89% powered to detect 35% risk reduction; projected H1 2025.
- No new safety signals observed; 407 patients enrolled across 100+ centers in US, EU, Australia, and elsewhere.
- Phase 2 basket trial data for NSCLC and SCCHN accepted for presentations at ESMO and other fall meetings.