Updated results from the VERSATILE-002 Phase 2 clinical trial indicate that Versamune® HPV, in combination with KEYTRUDA® (pembrolizumab), shows promise 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, highlight a significant improvement in median overall survival compared to pembrolizumab alone.
The single-arm Phase 2 trial (n=53) demonstrated a median overall survival (mOS) of 30 months (95% CI: 19.7 months to not reached). This is a notable improvement over the 12-18 months mOS typically observed with pembrolizumab monotherapy, as cited in previous studies. The objective response rate (ORR) was 36% (19/53 patients), and the disease control rate (DCR) reached 77% (41/53 patients).
Significant Tumor Shrinkage Observed
Notably, 21% of patients (11/53) experienced deep tumor responses, with shrinkage ranging from 90% to 100%. A complete response was observed in 9% of patients (5/53). These results suggest a potentially durable and effective anti-tumor response with the combination therapy.
Tolerability and Safety
The combination therapy was generally well-tolerated. Treatment-related adverse events of Grade ≥3 were reported 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 Phase 3 Trial Planned
Building on these promising Phase 2 results, PDS Biotech plans to initiate the VERSATILE-003, a global, randomized, controlled Phase 3 clinical trial, later this year. This trial will evaluate Versamune® HPV plus pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with HPV16-positive R/M HNSCC with CPS ≥1.
Market Opportunity
The global HNSCC market is projected to reach $4.5 billion by 2027, presenting a substantial commercial opportunity for PDS Biotech if the Phase 3 trial is successful and leads to regulatory approval. Versamune® HPV has already been granted Fast Track designation by the FDA, potentially accelerating its path to market.
About Versamune® HPV
Versamune® HPV is PDS Biotech's lead investigational targeted immunotherapy. It is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
