PDS0101 Plus Keytruda Elicits Survival Response in Head and Neck Cancer

Among patients with HPV15-positive first-line recurrent and/or metastatic head and neck squamous cell cancer, treatment with the combination of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) elicited a median overall survival more than three years among a select group of patients, it has been announced.

For patients with a Combined Positive Score (CPS) of at least 1, meaning at least 1% of their tumor cells or immune cells in the tumor express the protein PD-L1,the median overall survival among patients treated with the combination was 39.3 months, according to a news release from PDS Biotechnology Corporation announcing final topline survival data from the VERSATILE-002 phase 2 clinical trial.

Fifty-three patients were enrolled in the first-line recurrent and/or metastatic head and neck squamous cell cancer arm of the trial, for whom PDS0101 was administered via subcutaneous injection with IV infusion of Keytruda for the first four treatment cycles, with the fifth and final subcutaneous dose of PDS0101 was administered during cycle 12. During every other cycle where PDS0101 was not administered, monotherapy with Keytruda was administered, which continued until disease progression, death or cycle 35.

Patient survival, according to the news release, was similar across patient demographics and clinical characteristics such as age, CPS status and prior treatment.

“We believe this final readout of topline survival data from our VERSATILE-002 clinical trial supports the durable clinical effect of PDS0101 with similarly promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers,” said Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, in a statement included in the news release. “We believe PDS0101, which is simple and easy to administer, brings new hope to the rapidly growing population of HPV16-positive head and neck cancer patients. We look forward to publishing the full data set for this trial later this year.”

“With these results, PDS Biotech is well positioned for leadership in the largest and most rapidly growing segment of HNSCC in the US and Europe. HPV16-positive HNSCC constitutes a significant and rapidly growing unmet medical need, and a targeted therapy to treat the underlying cause of the disease is urgently needed. We believe that oncologists will continue to prioritize therapies that give their patients the best chance for survival. With PDS0101 plus pembrolizumab, an added benefit appears to be that the combination is well tolerated, and no patients discontinued the trial due to treatment-related adverse events,” Frank Bedu-Addo, President and CEO of PDS Biotech, said in the news release.

The VERSATILE-002 trial, according to its listing on clinicaltrials.gov, is currently active at 23 locations around the world. It is estimated to be completed in June 2025, according to the listing.

PDS0101, according to the National Cancer Institute, is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. As explained by PDS Biotechnology, It is an HPV-specific T cell-stimulating immunotherapy administered subcutaneously, or under the skin, that has demonstrated the potential to stimulate high levels of HPV16-specific CD8+ and CD4+ T cells in patients by activating multiple immune pathways. It has, according to the company, based on the data from VERSATILE-002 been granted HPV Fast Track designation by the U.S. Food and Drug Administration, making it eligible for priority review by the agency.

References

1. “PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer,” news release, Aug. 25, 2025; https://www.globenewswire.com/news-release/2025/08/25/3138462/37149/en/PDS-Biotech-Announces-Final-Topline-Survival-Data-from-VERSATILE-002-Phase-2-Trial-in-Head-and-Neck-Cancer.html
2. “Study of PDS0101 and Pembrolizumab Combination I/​O in Subjects with HPV16 + Recurrent And/​or Metastatic HNSCC (VERSATILE002),” https://www.clinicaltrials.gov/study/NCT04260126

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