August 25, 2025 — PDS Biotechnology Corporation (Nasdaq: PDSB) announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial, which evaluated PDS0101 (Versamune® HPV) + Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.
The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1, compared to 17.9 months with standard of care pembrolizumab or pembrolizumab + chemotherapy.
53 patients were enrolled in the 1L R/M HNSCC arm of the trial. PDS0101 was administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles, with pembrolizumab monotherapy administered on alternating cycles until disease progression, death, or cycle 35.
According to Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, the company anticipates publishing the full data set for this trial later this year. Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, said that the company is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe with these results.
Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
Source: PDS Biotechnology
