NEW YORK – PDS Biotech on Thursday said it plans to begin a Phase III trial of its HPV-targeted immunotherapy PDS0101 with Merck's Keytruda (pembrolizumab) in patients with unresectable, recurrent, or metastatic HPV 16-positive head and neck cancer.
The VERSATILE-003 trial will take place at up to 100 sites globally and compare the PDS0101-Keytruda combination to Keytruda alone. PDS will submit an amended investigational new drug application for the study to the US Food and Drug Administration in the third quarter of 2023. The company said it also has completed tech transfer, scale-up, and manufacturing activities required to initiate the trial.
PDS reported data last year showing the PDS0101-Keytruda combination led to an objective response rate of 41 percent and an overall survival rate of 87 percent at nine months in patients with HPV 16- and PD-L1-positive recurrent or metastatic head and neck cancer. Also in 2022, the combination was granted fast track designation for the treatment of recurrent or metastatic HPV 16-positive head and neck cancer.
PDS, based in Florham Park, New Jersey, is also studying PDS0101 in a trial including HPV-positive anal, cervical, penile, vaginal, and vulvar cancers; as a first-line treatment plus chemo for locally advanced cervical cancer; and with Keytruda in pre-metastatic HPV-associated oropharyngeal cancer.