PDS Biotech meets efficacy threshold in mid-stage trial for head and neck cancer therapy
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PDS Biotechnology Corporation (NASDAQ:PDSB) announced Wednesday that Stage two of its Phase 2 trial for its lead asset PDS0101 in head and neck cancer reached the efficacy threshold with Merck’s (NYSE:MRK) anti-PD-1 therapy, Keytruda.
The single-arm trial called VERSATILE-002 is designed to evaluate PDS0101 immunotherapy with immune checkpoint inhibitor Keytruda (pembrolizumab) in recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
According to the company, in its immune checkpoint inhibitor naïve arm, 14 out of 54 patients indicated either a complete or partial response on two consecutive scans, thus reaching the efficacy threshold. PDS Biotechnology (PDSB) has not yet conducted imaging evaluations for all patients.
“Achieving the efficacy threshold in VERSATILE-002 is an important milestone for the Company, especially as it has been achieved ahead of the full efficacy evaluation for this cohort,” medical chief of PDSB Dr. Lauren Wood remarked.
At the recent American Society of Clinical Oncology (OTC:ASCO) Annual Meeting, the company highlighted nine confirmed responses in 34 evaluable patients. With the latest update, the number of confirmed responses reached 14.
Ahead of a planned randomized, controlled Phase 3 trial called VERSATILE-003, PDS Biotechnology (PDSB) expects to submit an amended Investigational New Drug (IND) application for PDS0101 to the FDA in Q3 2023.