In HPV15+ first-line recurrent and/or metastatic head and neck most cancers, PDS0101 and Keytruda elicited notable total survival: © inventory.adobe.com.
Amongst sufferers with HPV15-positive first-line recurrent and/or metastatic head and neck squamous cell most cancers, therapy with the mixture of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) elicited a median total survival greater than three years amongst a choose group of sufferers, it has been introduced.
For sufferers with a Mixed Optimistic Rating (CPS) of a minimum of 1, that means a minimum of 1% of their tumor cells or immune cells within the tumor specific the protein PD-L1,the median total survival amongst sufferers handled with the mixture was 39.3 months, in accordance with a information launch from PDS Biotechnology Company saying last topline survival information from the VERSATILE-002 part 2 medical trial.
Fifty-three sufferers have been enrolled within the first-line recurrent and/or metastatic head and neck squamous cell most cancers arm of the trial, for whom PDS0101 was administered through subcutaneous injection with IV infusion of Keytruda for the primary 4 therapy cycles, with the fifth and last subcutaneous dose of PDS0101 was administered throughout cycle 12. Throughout each different cycle the place PDS0101 was not administered, monotherapy with Keytruda was administered, which continued till illness development, dying or cycle 35.
Affected person survival, in accordance with the information launch, was comparable throughout affected person demographics and medical traits equivalent to age, CPS standing and prior therapy.
“We consider this last readout of topline survival information from our VERSATILE-002 medical trial helps the sturdy medical impact of PDS0101 with equally promising survival outcomes reported in two different lately revealed research, the IMMUNOCERV research, and the NCI-led research in HPV16-positive recurrent and/or metastatic cancers,” mentioned Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, in an announcement included within the information launch. “We consider PDS0101, which is straightforward and simple to manage, brings new hope to the quickly rising inhabitants of HPV16-positive head and neck most cancers sufferers. We sit up for publishing the complete information set for this trial later this yr.”
“With these outcomes, PDS Biotech is effectively positioned for management within the largest and most quickly rising phase of HNSCC within the US and Europe. HPV16-positive HNSCC constitutes a big and quickly rising unmet medical want, and a focused remedy to deal with the underlying explanation for the illness is urgently wanted. We consider that oncologists will proceed to prioritize therapies that give their sufferers the most effective likelihood for survival. With PDS0101 plus pembrolizumab, an additional advantage seems to be that the mixture is effectively tolerated, and no sufferers discontinued the trial as a result of treatment-related opposed occasions,” Frank Bedu-Addo, President and CEO of PDS Biotech, mentioned within the information launch.
The VERSATILE-002 trial, in accordance with its itemizing on clinicaltrials.gov, is at present lively at 23 places around the globe. It’s estimated to be accomplished in June 2025, in accordance with the itemizing.
PDS0101, in accordance with the Nationwide Most cancers Institute, is a vaccine produced from particular peptides which will assist the physique construct an efficient immune response to kill tumor cells. As defined by PDS Biotechnology, It’s an HPV-specific T cell-stimulating immunotherapy administered subcutaneously, or underneath the pores and skin, that has demonstrated the potential to stimulate excessive ranges of HPV16-specific CD8+ and CD4+ T cells in sufferers by activating a number of immune pathways. It has, in accordance with the corporate, primarily based on the info from VERSATILE-002 been granted HPV Quick Observe designation by the U.S. Meals and Drug Administration, making it eligible for precedence evaluate by the company.
References
- “PDS Biotech Pronounces Last Topline Survival Knowledge from VERSATILE-002 Section 2 Trial in Head and Neck Most cancers,” information launch, Aug. 25, 2025; https://www.globenewswire.com/news-release/2025/08/25/3138462/37149/en/PDS-Biotech-Pronounces-Last-Topline-Survival-Knowledge-from-VERSATILE-002-Section-2-Trial-in-Head-and-Neck-Most cancers.html
- “Research of PDS0101 and Pembrolizumab Mixture I/O in Topics with HPV16 + Recurrent And/or Metastatic HNSCC (VERSATILE002),” https://www.clinicaltrials.gov/research/NCT04260126
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