PDS (PDSB) BIOTECH Phase 2 Data Published in JAMA Oncology With 39.3-Month Survival
VERSATILE-002 results for PDS0101 plus pembrolizumab show 39.3 months median overall survival in checkpoint-inhibitor-naive HPV16-positive head and neck cancer.
PDS Biotechnology (PDSB) said results from its Phase 2 VERSATILE-002 trial of PDS0101 combined with pembrolizumab in HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma were published in the September 17, 2026 issue of JAMA Oncology. In the immune checkpoint inhibitor-naive population with PD-L1 CPS of 1 or higher, median overall survival came in at 39.3 months (95% CI, 23.9 to not estimable). The company cited a best published figure of 17.9 months for standard-of-care pembrolizumab or pembrolizumab plus chemotherapy, while noting that no head-to-head trials have been performed.