Business
PDS Biotech Announces Presentation of Efficacy and Safety Data from VERSATILE-002 Phase 2 Clinical Trial in Recurrent or Metastatic Head and Neck Cancer at ASCO 2022
Preliminary data from first 19 patients treated with PDS0101 in combination with KEYTRUDA® (pembrolizumab) demonstrates 41% response rate thus far for first
About this update from Pds Biotechnology Corporation
[{"type":"text","content":"Preliminary data from first 19 patients treated with PDS0101 in combination with KEYTRUDA® (pembrolizumab) demonstrates 41% response rate thus far for first line recurrent or metastatic head and neck cancer, in comparison to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy for recurrent or metastatic head and neck cancer* 76.5% of patients had either disease stabilization or tumor shrinkage 89% of patients alive at median 9 months suggesting survival benefit Combination treatment well tolerated to date. 94% of patients received 4/5 PDS0101 doses with no treatment-related grade 3 or higher adverse events Company to host conference call and webcast on June 7, 2022 at 8:00 am ET FLORHAM PARK, N.J., May 26, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines, today announced an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3-7, 2022 in Chicago and online. VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune® technology, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab). The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-naïve patients at a prespecified interim analysis point. In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA® 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles (Cycles 1-4) and again on Cycle 12; KEYTRUDA® treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy. Highlights of the abstract from 19 patients (safety) with available imaging data for 17 of the 19 (efficacy) in the VERSATILE-002 clinical trial include: Response rates th...