PDS Biotech Announces Updated Data From VERSATILE-002 Phase 2 Study In HNSCC

(RTTNews) - PDS Biotechnology Corporation (PDSB) Monday announced updated data from the VERSATILE-002 Phase 2 study evaluating Versamune HPV in combination with Merck's Keytruda for the treatment of patients with HPV16-positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Data from the study showed median and overall survival rate of 20 percent; objective response rate of 36 percent; and disease control rate of 77 percent in HNSCC patients treated with Versamune HPV plus Keytruda. Further, 21 percent of patients experienced 90 percent-100 percent tumor shrinkage.

As of the latest data cut of the study on May 17, 2024, Versamune HPV plus Keytruda continued to be well tolerated in this population.

The data were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

A Phase 3 study to evaluate Versamune HPV plus Keytruda compared to Keytruda monotherapy as first line treatment in patients with HPV16-positive R/M HNSCC is planned to start this year.