On June 12, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a data update from its ongoing VERSATILE-002 Phase 2 clinical trial (Press release, PDS Biotechnology, JUN 12, 2024, View Source [SID1234644282]). VERSATILE-002 is evaluating Versamune HPV + KEYTRUDA (pembrolizumab) in patients with HPV16-positive head and neck squamous cell cancer ("HNSCC").
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The Kaplan-Meier analysis described below captures the survival data for immune checkpoint inhibitor ("ICI") naïve patients from the ongoing VERSATILE-002 Phase 2 clinical trial. All patients whose data are reported in the Kaplan-Meier analysis are properly censored to confirm their follow-up and survival status.
Based on a data cut as of May 17, 2024, the updated survival data for the cohort of ICI naïve patients after an additional follow-up of approximately 6 months in the VERSATILE-02 Phase 2 clinical trial with a total of 53 enrolled patients was as follows:
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mOS is 30 months, consistent with data presented at the Company’s Key Opinion Leader event on May 9, 2024, which was based on a data cut as of November 30, 2023.
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27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.
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The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of the patients continue to be followed for survival.
Full data from the May 17, 2024 data cut are expected to be announced in Q3 2024.
Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, "In recurrent and/or metastatic HNSCC objective response rate and progression-free survival have generally not translated into increased survival, and under current standards of care survival rates are well established to be less than 18 months. We believe that our VERSATILE-002 clinical trial and triple combination trial provide us with the critical survival information needed to effectively design the statistical primary endpoint in our planned Phase 3 trial".
The Company continues to advance its clinical strategy, which consists of a three arm registrational trial in first line treatment of HPV16-positive recurrent/metastatic HNSCC. The planned trial has two active arms: the double combination of Versamune HPV + pembrolizumab, and the triple combination of Versamune HPV + PDS01ADC + pembrolizumab. PDS01ADC is the Company’s tumor-targeted IL-12-fused antibody-drug conjugate ("ADC"), which has shown promise in ongoing Phase 2 clinical trials including a Phase 2 clinical trial of Versamune HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.