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Cancer

PDS Biotechnology Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Clinical Trial

Strategic Insights

— 2 min read

PDS Biotechnology Corporation, a late-stage immunotherapy company, has announced final topline survival data from its Phase 2 clinical trial, VERSATILE-002. The trial evaluated the safety and efficacy of PDS0101 (Versamune(R) HPV) in combination with pembrolizumab for patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.

The trial enrolled 53 patients and demonstrated a median overall survival (mOS) of 39.3 months in patients with CPS greater-than or equal to 1. This is the best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy, which is 17.9 months. The trial showed that high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 promoted durable patient survival, with similar outcomes across patient demographics and clinical characteristics.

"We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers," said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech.

Key Takeaways:

  • PDS Biotechnology Corporation announced final topline survival data from its Phase 2 clinical trial, VERSATILE-002, demonstrating a median overall survival (mOS) of 39.3 months in patients with CPS greater-than or equal to 1.
  • The trial enrolled 53 patients and evaluated the safety and efficacy of PDS0101 (Versamune(R) HPV) in combination with pembrolizumab for patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.
  • High levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101 promoted durable patient survival, with similar outcomes across patient demographics and clinical characteristics.
  • The trial's results are the best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy, which is 17.9 months.
  • Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, believes the trial's results support the durable clinical effect of PDS0101, with promising survival outcomes reported in two other recently published studies.

Statistics:

  • Median overall survival (mOS): 39.3 months
  • Lower limit of the 95% confidence interval: 23.9 months
  • Upper limit of the 95% confidence interval: Not yet estimable
  • Number of patients enrolled: 53
  • Combination therapy: PDS0101 (Versamune(R) HPV) + pembrolizumab
  • Disease: HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer

Sources:

  • "PDS Biotechnology Corporation Announces Final Topline Survival Data from Phase 2 Clinical Trial of Versamune(R) HPV and Keytruda(R) in HPV16-Positive Head and Neck Cancer" (Globe Newswire, August 25, 2025)
  • "Versamune(R) HPV" (PDS Biotechnology Corporation website)

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