PDS Biotech announces final topline survival data from VERSATILE-002 trial.

PDS Biotech announces final topline survival data from its VERSATILE-002 Phase 2 trial, showing a median overall survival of 39.3 months in patients with CPS ≥ 1. This is the best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy, which has a median overall survival of 17.9 months. The VERSATILE-003 Phase 3 trial is currently underway.

PDS Biotechnology (Nasdaq: PDSB) has announced the final topline survival data from its VERSATILE-002 Phase 2 clinical trial, which evaluated the combination of PDS0101 (Versamune® HPV) and Keytruda® (pembrolizumab) in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (1L R/M HNSCC). The trial demonstrated a median overall survival (mOS) of 39.3 months in patients with a high level of tumor infiltration (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 treatment combination was well-tolerated, with no patients discontinuing due to treatment-related adverse events. The company plans to publish the full dataset later this year while its VERSATILE-003 Phase 3 trial is currently in progress.

The impressive 39.3-month median overall survival is a substantial improvement over the standard of care outcomes, suggesting more than a 100% improvement in survival outcomes. The lower confidence interval bound of 23.9 months still substantially exceeds standard care outcomes, while the upper limit remains unestablished, indicating some patients are experiencing even longer survival benefits.

The company attributes this durability to the high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, which appears effective across various patient demographics and clinical characteristics. The combination therapy's administration protocol is straightforward: subcutaneous PDS0101 injections alongside pembrolizumab infusions for the first 4 treatment cycles, followed by a final PDS0101 dose at cycle 12, with pembrolizumab monotherapy continuing between PDS0101 administrations.

The data from VERSATILE-002 aligns with two other recently published studies (IMMUNOCERV and the NCI-led study), providing consistent evidence across multiple investigations. With the Phase 3 VERSATILE-003 trial already in progress, this therapy is positioned to potentially address a significant unmet need in the fastest-growing segment of head and neck cancers.

References:
[1] https://www.stocktitan.net/news/PDSB/pds-biotech-announces-final-topline-survival-data-from-versatile-002-t3jbj3sv996b.html