PDS Biotechnology Corporation announced updated results from its VERSATILE-002 Phase 2 clinical trial, revealing that Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) significantly improved survival outcomes in patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) when used as a first-line treatment. The data, presented at the European Society for Medical Oncology (ESMO) Congress 2024, highlight the potential of this combination therapy to address a critical unmet need in HNSCC treatment.
The VERSATILE-002 trial, a single-arm Phase 2 study, enrolled 53 patients with HPV16-positive R/M HNSCC. The latest data cut, taken on May 17, 2024, showed that the combination of Versamune® HPV and pembrolizumab was well-tolerated. As of the data cut, 10 patients remained on the study treatment, and 27 patients (including the 10 on treatment) continued to be followed for survival, with a median patient follow-up of 16 months.
Survival and Response Rates
The trial data demonstrated a median overall survival (mOS) of 30 months, with a lower 95% confidence interval of 19.7 months. This is a notable improvement compared to the published mOS for pembrolizumab monotherapy, which ranges from 12 to 18 months. The objective response rate (ORR) was 36% (19 out of 53 patients), significantly higher than the 19-25% ORR typically observed with pembrolizumab alone. Furthermore, the disease control rate (DCR) was 77% (41 out of 53 patients).
Deep Tumor Responses
Notably, 21% (11 out of 53) of patients experienced deep tumor responses, characterized by tumor shrinkage of 90-100%. Complete responses were observed in 9% (5 out of 53) of patients, indicating the potential for significant and durable tumor control with this combination therapy.
Safety Profile
The combination therapy demonstrated a manageable safety profile. Treatment-related adverse events of Grade =3 were observed in 9 patients (Grade 3, n=8 and Grade 4, n=1).
Future Directions
Building on these promising results, a global, randomized, controlled Phase 3 clinical trial, VERSATILE-003, is planned to commence 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 CPS =1. The VERSATILE-003 trial aims to confirm the superior efficacy of the combination therapy in a larger, controlled study setting, potentially establishing a new standard of care for this patient population.
