FDA Grants Fast Track Designation to PDS0101 Plus Pembrolizumab in Advanced Head and Neck Cancer
Author: Ariana Pelosci Source: www.cancernetwork.com Fast track designation was granted to PDS0101 plus pembrolizumab, which is currently being assessed in the phase 2 VERSATILE study in patients with recurrent or metastatic human papillomavirus 16–positive head and neck cancer. PDS0101 plus pembrolizumab (Keytruda) has been granted fast track designation by the FDA for patients with recurrent or metastatic human papillomavirus (HPV) 16–positive head and neck cancer, according to a press release from PDS Biotechnology.1 The combination is currently being investigated in the phase 2 VERSATILE-002 study (NCT04260126) in the aforementioned patient population. PDS0101 is a subcutaneous T cell HPV-specific immunotherapeutic that can encourage high levels of CD8-positive and CD-4 positive T cells. This is achieved by activating numerous immune pathways. These T cells have been observed to target different tumors that have occurred as a result of HPV16 infection. “We are thrilled that the FDA has granted fast track designation for PDS0101 in combination with [pembrolizumab],” Frank Bedu-Addo, PhD, chief executive officer of PDS Biotech, said in the press release. “The HPV-associated head and neck cancer prevalence continues to rise, leaving this affected group with limited treatment options to date. Receiving this designation underscores the potential of the Versamune® platform and the need for a new therapy that may improve outcomes for those with this devastating disease.” At the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, results from the trial were presented.2 In stage 1 of the study, 17 patients were included who were checkpoint inhibitor naïve with 4 [...]