other_material
confidence high
sentiment positive
materiality 0.75
PDS Biotech reports positive extended follow-up data for Versamune HPV Phase 2 in head and neck cancer
PDS Biotechnology Corp
- VERSATILE-002: mOS of 39.3 months (CPS≥20) vs ~15 months for pembrolizumab; median follow-up 18.4 months.
- mOS of 30.0 months (CPS≥1) and 29.5 months (CPS 1-19), exceeding historical pembrolizumab results.
- Phase 3 VERSATILE-003 (n=351) enrolling; primary endpoint mOS with two interim analyses planned.
- Phase 2 window trial: 70% stable disease with Versamune HPV alone; 100% SD/PR with combo; met ctDNA endpoint.
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