Updated data from the VERSATILE-002 Phase 2 study, presented at the European Society for Medical Oncology (ESMO) Congress 2024, highlights the potential of Versamune HPV in combination with Merck's Keytruda (pembrolizumab) for treating patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
The study showcased a 36% objective response rate (ORR) among HNSCC patients treated with the Versamune HPV and Keytruda combination. Furthermore, the disease control rate (DCR) reached 77%, indicating a substantial proportion of patients experiencing either tumor shrinkage or disease stabilization. The median overall survival rate was reported at 20%.
Significant Tumor Shrinkage Observed
Notably, 21% of the patients in the study experienced a 90%-100% reduction in tumor size, underscoring the potential for significant clinical benefit with this therapeutic approach. As of the data cut-off date of May 17, 2024, the combination therapy continued to exhibit a favorable safety profile, with Versamune HPV plus Keytruda being well-tolerated within the study population.
Planned Phase 3 Trial
Building on these promising Phase 2 results, a Phase 3 clinical trial is slated to commence this year. This trial will evaluate Versamune HPV in conjunction with Keytruda compared to Keytruda monotherapy as a first-line treatment option for patients with HPV16-positive R/M HNSCC. The study aims to further establish the efficacy and safety of this combination regimen and potentially offer a new standard of care for this patient population.
