Enrollment is Complete for Trial of PDS0101 in HPV16-Associated Head and Neck Cancer

Enrollment has been completed in the VERSATILE-002 trial, a phase 2 study of PDS0101 for the treatment of advanced human papillomavirus-associated head and neck cancer that has returned or spread.

Enrollment has been completed in the VERSATILE-002 trial (NCT04260126), a phase 2 study of PDS0101 for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer that has returned or spread, according to a press release by PDS Biotechnology.1

PDS0101 is a clinical stage immunotherapy. VERSATILE-002 is being studied in combination with pembrolizumab (Keytruda).

The phase 2, open-label study has an estimated enrollment of 96 participants with an estimated completion date of July 2024. The primary end point is objective response rate (ORR). Secondary end points include progression-free survival, overall survival, and incidents of treatment-emergent adverse events. Other end points include duration of response and immune response.2

The study will include patients from 2 groups. The first group will include patients who have never been treated with a checkpoint inhibitor while the second group will include patients who have failed multiple prior lines of therapy, including immune checkpoint inhibitors.

During the study, patients will receive pembrolizumab followed by PDS0101 5 times over the course of the study. After the 5 doses are completed, pembrolizumab monotherapy will be administered up to cycle 35 or until disease progression. 

In order to participate in the study, patients must be 18 years of age or older, have confirmed HPV16 infection, not have received any immunological therapy for metastatic disease, have adequate organ function, recovered from any major surgery, and have an ECOG score of 0 or 1. Patients who are pregnant, received prior radiotherapy within 2 weeks of the start of study treatment, have undergone prior allogeneic hematopoietic stem cell transplantation, known active central nervous system metastases, or a history if interstitial lung disease, are not eligible to participate.

The trial comes after the positive results of another phase 2 trial (NCT04287868) looking at PDS0101 in combination with the investigational immunotherapies NHS-IL12 and M7824 in patients with advanced, previously treated, HPV-related cancers. The ORR was 42%. In 58% of patients who were checkpoint inhibitor refractory, tumor reduction was reported. This population had an ORR of 42%.

“The early data from these initial studies suggest that Versamune®-based immunotherapies administered in combinations that include a checkpoint inhibitor, may have the potential to enhance the immune system’s ability to induce a more powerful and targeted anti-tumor response,” said Lauren V. Wood, MD, chief medical officer of PDS Biotech in a press release. “There is an enormous unmet medical need for more effective treatment of advanced HPV-related cancers and specifically, head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to sharing data from this trial as they become available.”

The study recruited in locations across California, Florida, Kentucky, Michigan, Minnesota, Missouri, New Jersey, North Caroline, Ohio, South Carolina, Tennessee, and West Virginia.

PDS Biotech completes enrollment of lead-in safety cohort in VERSATILE-002 phase 2 combination trial of PDS0101-KEYTRUDA® in recurrent or metastatic head and neck cancer. News release. September 9, 2021. Accessed September 10, 2021. https://bit.ly/3yZAgsc
Study of PDS0101 and pembrolizumab combination I/O in subjects with HPV16 + recurrent and/or metastatic HNSCC (VERSATILE002). ClinicalTrials.gov. Accessed September 10, 2021. https://bit.ly/3E5E5zJ.