PDS Biotech publishes VERSATILE-002 Phase 2 results for PDS0101 in JAMA Oncology
The head and neck cancer trial combining PDS0101 with pembrolizumab reported 39.3-month median overall survival in checkpoint-inhibitor-naive patients, as the company pursues a partner for further development.
PDS Biotechnology Corporation announced on September 22, 2026 that results from its Phase 2 VERSATILE-002 trial of PDS0101 combined with pembrolizumab were published in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association1. The study evaluated the combination in HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma.
Among immune checkpoint inhibitor naive patients with PD-L1 CPS of 1 or higher, median overall survival was 39.3 months, compared with a previously published best result of 17.9 months for standard of care pembrolizumab or pembrolizumab plus chemotherapy1. Objective response rate in that group was 36% by investigator review, including 5 of 53 patients with complete responses, and 34% by central review, including 6 of 53 complete responses1, compared with a published 19% ORR for standard of care pembrolizumab alone1. Safety data showed 13.8% Grade 3 or higher treatment-related adverse events, one Grade 4 event a year after therapy, and no Grade 5 events1, versus a published 17% rate of Grade 3 or higher adverse events for standard of care pembrolizumab1.
The trial enrolled 88 patients across twenty-six oncology centers in the US, UK and Ireland, with 87 treated and 75 in the modified intention-to-treat population, split into 53 checkpoint-inhibitor-naive and 22 checkpoint-inhibitor-resistant patients1. It was led by Dr. Jared Weiss of the Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill.
The company said it is pursuing strategic partnerships or other externally funded opportunities for Phase 3 development of PDS01011, while prioritizing its PDS0301 program in metastatic colorectal cancer. The filing noted that PDS Biotech had disclosed a PIPE financing led by Nant Capital, under which NantWorks, LLC, an affiliate of Nant Capital, received a one-year exclusive right to negotiate an exclusive license to PDS01011.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.