PDS Biotechnology Corporation has announced promising final survival data from its VERSATILE-002 Phase 2 clinical trial, which evaluated the combination of its immunotherapy PDS0101 (Versamune® HPV) and pembrolizumab (Keytruda®) in patients with HPV16-positive recurrent or metastatic head and neck squamous cell cancer. The trial reported a median overall survival of 39.3 months for patients with a combined positive score (CPS) of ≥ 1, significantly outperforming the best available standard of care with pembrolizumab alone, which has a median overall survival of 17.9 months. The results suggest a durable clinical benefit associated with PDS0101, as it encourages the production of HPV16-specific CD8+ T cells, and the treatment was well tolerated with no patients discontinuing due to adverse effects.

Full report : PDS Biotechnology Reports 39.3-Month Median Overall Survival in VERSATILE-002 Trial for HPV16-Positive Head and Neck Cancer.