FX.co ★ PDS Biotech Announces Updated Data From VERSATILE-002 Phase 2 Study In HNSCC

PDS Biotechnology Corporation (PDSB) announced on Monday the latest results from the VERSATILE-002 Phase 2 trial, which is assessing the efficacy of Versamune HPV in combination with Merck's Keytruda for patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

The trial data revealed a median survival rate and an overall survival rate of 20 percent, an objective response rate of 36 percent, and a disease control rate of 77 percent in the patient cohort treated with Versamune HPV plus Keytruda. Additionally, 21 percent of patients experienced significant tumor shrinkage in the range of 90 percent to 100 percent.

Based on the latest data cut as of May 17, 2024, Versamune HPV combined with Keytruda continues to show a favorable tolerance profile within this patient population.

These findings were shared during the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

A Phase 3 study is anticipated to commence this year, aiming to compare the efficacy of Versamune HPV plus Keytruda against Keytruda monotherapy as a first-line treatment for patients with HPV16-positive R/M HNSCC.