PDS Biotech Announces Positive Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer

PDS Biotech announced final topline survival data from the VERSATILE-002 Phase 2 trial in head and neck cancer. Median overall survival (mOS) was 39.3 months in patients with CPS ≥ 1. The combination of PDS0101 and pembrolizumab was well-tolerated, with no patients discontinuing due to treatment-related adverse events. A Phase 3 trial, VERSATILE-003, is currently underway.

PDS Biotechnology Corporation (Nasdaq: PDSB) has announced significant results from the VERSATILE-002 Phase 2 clinical trial, which evaluated the combination of PDS0101 and pembrolizumab in patients with HPV16-positive first-line recurrent/metastatic head and neck cancer. The trial demonstrated a median overall survival (mOS) of 39.3 months in patients with a high tumor mutational burden (CPS ≥ 1), significantly outperforming the best published standard of care result of 17.9 months [1].

The VERSATILE-002 trial enrolled 53 patients and showed durable patient survival promoted by high levels of long-lasting HPV16-specific CD8+ T cells. The combination therapy was well-tolerated, with no patients discontinuing the trial due to treatment-related adverse events. This is a promising result, as the trial's success could lead to a new standard of care for HPV16-positive head and neck cancer patients.

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, stated, "This final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies" [1]. Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech, added, "We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated" [1].

PDS Biotech is now well-positioned for leadership in the largest and most rapidly growing segment of head and neck squamous cell carcinoma (HNSCC) in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. The company is currently conducting a Phase 3 trial, VERSATILE-003, to further validate these promising results [1].

The success of the VERSATILE-002 trial is a significant milestone for PDS Biotech and could have a substantial impact on the treatment of head and neck cancer. As the company continues to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers, investors should closely monitor the progress of the VERSATILE-003 trial and any future clinical data releases.

References:
[1] https://www.globenewswire.com/news-release/2025/08/25/3138462/37149/en/PDS-Biotech-Announces-Final-Topline-Survival-Data-from-VERSATILE-002-Phase-2-Trial-in-Head-and-Neck-Cancer.html