PDS Biotech reports durable 30.0-month median OS from VERSATILE-002 in HPV16+ HNSCC

PDS Biotechnology Corp

Median overall survival (mOS) steady at 30.0 months with ~4.5 months additional follow-up; lower 95% CI increased to 23.9 months.
Median PFS: 6.3 months; ORR: 35.8%; disease control rate: 77.4%; median DoR: 21.8 months.
VERSATILE-003 is the only ongoing Phase 3 trial specifically addressing 1L r/m HPV16-positive HNSCC.
Data presented at ASCO 2025; no new safety signals; 22 of 53 patients still being followed.

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