PDS Biotechnology has completed enrolment of patients in VERSATILE-002 Phase II trial of PDS0101 administered along with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of advanced human papillomavirus (HPV)16 positive metastatic head and neck squamous cell carcinoma (HNSCC).

The open-label, multicentre, single-arm study will assess the efficacy and safety of PDS0101 with KEYTRUDA in adults with HPV16-positive HNSCC.

It intends to investigate two patient populations with HPV16-positive head and neck cancer patients whose cancer has returned or spread.

The first group includes individuals who have not been previously treated with an immune checkpoint inhibitor (ICI) and are PD-L1 positive and the second group who have failed treatments including ICI therapy.

Preliminary data of PDS0101 with KEYTRUDA demonstrated that out of 19 patients, 17 had either disease stabilisation or tumour shrinkage.

At nine months, the overall survival rate of these patients was 87%.

PDS Biotech chief medical officer Dr Lauren Wood said: “Preliminary data reported at ASCO 2022 and highlighted at our October 2022 Head and Neck Cancer KOL Roundtable suggest that PDS0101 in combination with KEYTRUDA may lead to improved outcomes in ICI naive, recurrent or metastatic HNSCC patients.

“We now look forward to reporting updated data from the VERSATILE-002 trial at ASCO 2023 as the next step towards a planned global confirmatory randomised, controlled trial investigating the combination of PDS0101 and KEYTRUDA in this same patient population.”

A new investigational HPV-targeted immunotherapy, PDS0101 is injected subcutaneously alone or combined with other immunotherapies and cancer treatments.