PDS Biotechnology reports extended survival in VERSATILE-002 CPS 1-19 cohort

PDS Biotechnology (PDSB) announced details of a sub-analysis of the cohort of patients with low PD-L1 expression, or CPS 1-19, from the final data for its recently completed VERSATILE-002 Phase 2 clinical trial. The VERSATILE-002 trial evaluated PDS0101 + Keytruda in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer. Approximately 60% of the patients enrolled in the VERSATILE-002 trial had low PD-L1 expression, a difficult to treat subset of the overall HNSCC patient population. The sub-analysis of this patient cohort shows: Median overall survival for patients within the CPS 1-19 cohort was 29.5 months. Published mOS in this CPS cohort was 10.8 months with Keytruda monotherapy and 12.3 months with Keytruda plus chemotherapy. The Company announced mOS results for the full study population of 39.3 months from the VERSATILE-002 trial on August 25, 2025, and the full data set for the trial is expected to be published later this year.