PDS Biotech Reports 39.3-Month Survival in Head, Neck Cancer Trial

PDS Biotechnology has reported impressive final phase 2 results from its VERSATILE-002 trial evaluating PDS0101, a therapeutic cancer vaccine, combined with Keytruda in HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The combination therapy achieved a median overall survival (mOS) of 39.3 months in patients with a combined positive score (CPS) of one or greater, significantly surpassing the 17.9 months mOS typically seen with Keytruda monotherapy or chemoimmunotherapy. The treatment regimen involved subcutaneous PDS0101 and intravenous pembrolizumab, which was administered until disease progression or death, with durable survival linked to strong HPV16-specific CD8+ T cell responses. PDS Biotech has initiated a phase 3 trial to compare this combination against Keytruda alone, aiming to confirm these promising results. Meanwhile, the broader recurrent or metastatic head and neck cancer drug pipeline remains active, with over 40 companies developing more than 40 therapies, including ongoing trials of novel combinations involving pembrolizumab. This evolving landscape reflects continued efforts to improve outcomes in this challenging cancer setting.