PDS0101 along with KEYTRUDA is used for the treatment of HPV16-positive metastatic head and neck squamous cell carcinoma. Credit: KGH / commons.wikimedia.org.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.