PDS Biotechnology announced updated data from the VERSATILE-002 trial, revealing promising results for Versamune-HPV in combination with Keytruda (pembrolizumab) 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 in Barcelona, Spain, highlight a significant improvement in overall survival compared to historical data for pembrolizumab monotherapy.
Improved Survival and Response Rates
The VERSATILE-002 trial data demonstrated a median overall survival (mOS) of 30 months (95% CI: 19.7 months to not reached) for the Versamune-HPV and Keytruda combination. This compares favorably to the published mOS of 12-18 months for pembrolizumab alone in similar patient populations. The objective response rate (ORR) was 36%, exceeding the published ORR of 19-25% for pembrolizumab. The disease control rate (DCR) reached 77%, indicating a substantial proportion of patients experiencing clinical benefit.
Deep and Complete Responses
Notably, 21% of patients in the trial experienced deep tumor responses, characterized by tumor shrinkage of 90-100%. Furthermore, 9% of patients achieved a complete response, suggesting the potential for durable remission in a subset of patients. These findings underscore the potential of the Versamune-HPV and Keytruda combination to induce significant anti-tumor activity in HPV16-positive HNSCC.
Safety Profile
Regarding safety, treatment-related adverse events of Grade 3 or higher were observed in 9 patients. This suggests that the combination regimen is generally well-tolerated, with a manageable safety profile. Further analysis of the adverse event data will be crucial to fully characterize the safety of the combination.
Implications for HNSCC Treatment
These data suggest that the combination of Versamune-HPV and pembrolizumab may offer a significant improvement over existing first-line treatment options for HPV16-positive recurrent/metastatic HNSCC. The observed increase in median overall survival, coupled with encouraging response rates and a manageable safety profile, warrants further investigation of this combination in larger, randomized clinical trials. The results offer hope for patients with this challenging cancer, where new treatment options are urgently needed.
