PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population

Core Insights - PDS Biotechnology Corporation announced that its combination therapy of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) achieved a median overall survival (mOS) of 29.5 months in patients with low PD-L1 expression (CPS 1-19), significantly outperforming Keytruda alone (10.8 months) and Keytruda plus chemotherapy (12.3 months) [1][7] Group 1: Clinical Trial Results - The VERSATILE-002 Phase 2 clinical trial evaluated the efficacy of PDS0101 in combination with Keytruda for patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell cancer [1][4] - Approximately 60% of the patients enrolled in the trial had low PD-L1 expression, indicating a challenging subset of the overall patient population [3] - The full study population reported an mOS of 39.3 months, with detailed data expected to be published later this year [3] Group 2: Expert Commentary - Prof. Kevin Harrington highlighted the significance of the results, noting the potential for a well-tolerated treatment option without chemotherapy for patients [2] - Dr. Kirk Shepard emphasized that the findings suggest PDS0101 may enhance survival outcomes for patients who typically have limited treatment options and poor prognosis [3] Group 3: Company Overview - PDS Biotechnology is focused on developing immunotherapy treatments that enhance the immune system's ability to target and kill cancer cells, with a pivotal clinical trial underway for advanced HPV16-positive head and neck squamous cell cancers [5] - The company is also exploring a triple combination therapy involving PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [5]