Versamune HPV/Pembrolizumab Meets Primary End Point in HPV16+ HNSCC Study

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The phase 2 VERSATILE-002 trial evaluating Versamune HPV with pembrolizumab met its primary end point in patients with first-line recurrent metastatic head and neck squamous cell cancer.

cancer cell or tumor illustration in high detail for medical education or science background, Generative AI: © LAYHONG - stock.adobe.com

cancer cell or tumor illustration in high detail for medical education or science background, Generative AI: © LAYHONG - stock.adobe.com


The combination of Versamune HPV (PDS0101) and pembrolizumab (Keytruda) led to a promising best overall response (BOR) of 34% in a cohort of 53 patients with human papillomavirus (HPV) 16-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), meeting the primary end point of the phase 2 VERSATILE-002 trial (NCT04260126).1

This cohort included patients who were naive to immune checkpoint inhibitors and had a PD-L1 combined positive score (CPS) of at least 1. The BOR was 48% among patients with a PD-L1 CPS of at least 20 (n = 21).

Notably, the population of 53 patients with a PD-L1 CPS of at least 1 had a median overall survival (OS) of 30 months, which is better than what is normally seen with immune checkpoint inhibitors at 7 to 18 months. Additionally, the median progression-free survival (PFS) was 6.3 months in patients with a PD-L1 CPS of at least 1 and 14.1 months in those with a PD-L1 CPS of at least 20.

Looking at safety, the combination of Versamune HPV plus pembrolizumab was well-tolerated.

Overall, these data from VERSATILE-002 indicate a durable response in patients with first-line recurrent and/or metastatic HNSCC with a CPS of at least 1.

About the Phase 2 VERSATILE-002 Trial

VERSATILE-002 is an open-label, multicenter, phase 2 trial which included patients aged 8 years and older with histologically confirmed, recurrent, metastatic, or persistent HNSCC.2 Once enrolled, patients were given 2 subcutaneous injections of Versamune HPV at a dose of 0.5 mL during cycles 1, 2, 3, 4, and 12. Pembrolizumab was given at a dose of 200 mg once every 3 weeks and was administered in combination with Versamune HPV as well as given as a monotherapy during cycles 5 to 11 and 13 to 35.

Patients were required to have a confirmed HPV 16 infection and a PD-L1 CPS of at least 1.All patients must have recovered from any toxicities associated with previous radiation therapy, had recurrent and/or metastatic disease per RECIST 1.1 criteria, adequate organ function, and an ECOG performance status of 0 or 1 to be eligible for enrollment in the study.

Among those included in the checkpoint inhibitor-naive cohort, patients must not have had prior immunological therapy for metastatic disease. Patients in the pretreated cohort must have had prior treatment with checkpoint inhibitors as monotherapy or in a combination. These patients must have received at least 2 doses or have undergone a minimum of 6 weeks of treatment and were required to have documented and radiologically confirmed clinical progression or recurrence.

In addition to the primary end point of BOR, secondary end points included PFS per RECIST 1.1 criteria, OS, and safety. Additional end points looked at in the study consisted of duration of response and anti-HPV 16 E6 and E7 immune responses.

In the press release from PDS Biotechnology Corporation, it was stated that an updated clinical strategy with a 2-part registrational trial focused on the triple combination of Versamune HPV with PDS01ADC, a novel, investigational, tumor-targeting IL-12–fused antibody-drug conjugate, and pembrolizumab as a first-line treatment for patients with HPV 16-positive recurrent/metastatic HNSCC will begin.1

The first part of this trial will focus on dose optimization, evaluating end points based on safety, and objective response rate. The second part of the trial will be randomized, and OS will serve as its primary end point.

REFERENCES:
  1. PDS Biotech VERSATILE-002 phase 2 clinical trial meets primary study endpoints in first line recurrent/metastatic HPV16-positive head and neck cancer. News release. PDS Biotechnology Corporation. May 9, 2024. Accessed May 13, 2024. https://tinyurl.com/22n39h5b
  2. Study of PDS0101 and pembrolizumab combination I/​O in subjects with HPV16 + recurrent and/​or metastatic HNSCC (VERSATILE002). ClinicalTrials.gov. Updated March 15, 2024. Accessed May 13, 2024. https://clinicaltrials.gov/study/NCT04260126
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