On September 16, 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 updated data from the VERSATILE-002 trial evaluating Versamune HPV (formerly PDS0101) in combination with KEYTRUDA (pembrolizumab) as a first-line (1L) treatment for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) (Press release, PDS Biotechnology, SEP 16, 2024, View Source [SID1234646661]). The data were presented during a poster session on September 14 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.
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As of the latest data cut of the VERSATILE-002 single-arm, Phase 2 trial on May 17, 2024, Versamune HPV plus pembrolizumab continued to be well tolerated in this 1L R/M HPV16-positive HNSCC population. Enrollment in the trial (n=53) is complete, 10 patients remain on study treatment and 27 patients (including the 10 on treatment) continue to be followed for survival. Median patient follow-up is 16 months. The data demonstrated the following:
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Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months; Published mOS for pembrolizumab is 12-18 months1,2
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Objective Response Rate (ORR) of 36% (19/53); Published ORR for pembrolizumab is 19-25%1,2
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Disease Control Rate (DCR) is 77% (41/53)
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21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%
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9% (5/53) of patients had a complete response
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Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)
"The updated response data we presented at ESMO (Free ESMO Whitepaper) show the strong clinical activity and durability of Versamune HPV plus pembrolizumab," said Jared Weiss, M.D., Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine at the University of North Carolina, and principal investigator of the VERSATILE-002 clinical trial. "Continued evaluation shows the promise of this combination in improving survival for patients with HPV16-positive HNSCC."
A global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, that will evaluate Versamune HPV plus pembrolizumab vs. pembrolizumab monotherapy as 1L treatment in patients with HPV16-positive R/M HNSCC with CPS ≥1 is planned to start this year.
"We’re encouraged to see that as the data from our VERSATILE-002 clinical trial have matured, responses continue to improve, suggesting durability of the Versamune HPV induced anti-tumor immune response," said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the VERSATILE-002 trial underscore our belief in the potential of the combination to be the first HPV-targeted immunotherapy for HNSCC, and a significant advancement in the treatment of the growing population of patients with HPV16-positive HNSCC. We are working toward initiating the VERSATILE-003 Phase 3 study this year."
Versamune HPV has been granted Fast Track designation by the FDA.
1.
Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI View Source
2.
Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01
No head-to-head studies have been performed comparing Versamune HPV with other treatments