PDS Biotechnology announces data from its VERSATILE-002 Phase 2 trial

PDS Biotechnology (PDSB) announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 + Keytruda in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer, 1L R/M HNSCC. 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. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12. On every other cycle where PDS0101 was not administered, pembrolizumab monotherapy was administered. This continued until disease progression, death, or to cycle 35. The median overall survival is 39.3 months in patients with CPS greater than or equal to 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable. Durable patient survival is promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 and was similar across patient demographics and clinical characteristics such as age, CPS status, and prior treatment.