PDS Biotech announced updated results from its VERSATILE-002 Phase 2 clinical trial, revealing that Versamune® HPV (formerly PDS0101) combined with KEYTRUDA® (pembrolizumab) demonstrates strong clinical activity and durability as a first-line treatment for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The data, presented at the European Society for Medical Oncology (ESMO) Congress 2024, underscore the potential of this combination to improve survival outcomes in this patient population.
The VERSATILE-002 trial, a single-arm Phase 2 study, enrolled 53 patients with HPV16-positive R/M HNSCC. As of the data cut on May 17, 2024, the combination therapy continued to be well-tolerated. The median patient follow-up was 16 months, with 10 patients remaining on study treatment and 27 being followed for survival.
Key Findings from VERSATILE-002
The updated data revealed a median overall survival (mOS) of 30 months (95% CI: 19.7 months to not reached). This compares favorably to published mOS data for pembrolizumab monotherapy, which typically ranges from 12 to 18 months. The objective response rate (ORR) was 36% (19/53 patients), while the disease control rate (DCR) reached 77% (41/53 patients). Notably, 21% (11/53) of patients experienced deep tumor responses, with tumor shrinkage ranging from 90% to 100%, and 9% (5/53) achieved a complete response.
Treatment-related adverse events of Grade ≥3 were observed in 9 patients (Grade 3, n=8; Grade 4, n=1), indicating a manageable safety profile.
Expert Commentary
"The updated response data we presented at ESMO 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."
VERSATILE-003: A Phase 3 Trial on the Horizon
Building on these promising results, PDS Biotech is planning to initiate a global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, later this year. This trial will evaluate Versamune® HPV plus pembrolizumab versus pembrolizumab monotherapy as a first-line treatment in patients with HPV16-positive R/M HNSCC with a CPS ≥1.
"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."
Versamune® HPV has been granted Fast Track designation by the FDA, highlighting its potential to address an unmet need in the treatment of HPV16-positive head and neck cancer.
