PDS Biotech (Nasdaq: PDSB) adopted an amended protocol for its Phase 3 VERSATILE-003 trial to add progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent/metastatic head and neck cancer.

Median overall survival (mOS) remains the primary endpoint for full approval; the company proceeded after the FDA 30-day IND review without objection, and management said the amendment could shorten trial duration and reduce costs.