What question did this study set out to answer?

To determine the efficacy and safety of the therapeutic HPV16-targeted immunotherapy PDS0101 combined with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.

September 18, 2026JAMA OncologyOpen Access

PDS0101 With Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

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Authors

JWJ. WeissUniversity of North Carolina at Chapel Hill JKJohn KaczmarMedical University of South Carolina ACAshish ChintakuntlawarMayo Clinic

Discussion

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Implication

Randomized trial reveals robust antitumor activity with PDS0101 and pembrolizumab in untreated HPV16-positive head and neck cancer, suggesting significant clinical benefit in first-line therapy.

Key Points

To determine the efficacy and safety of the therapeutic HPV16-targeted immunotherapy PDS0101 combined with pembrolizumab in patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.
Conducted a multicenter, phase 2 trial (VERSATILE-002; NCT04260126) across 26 oncology centers in the US, UK, and Ireland using a Simon 2-stage optimal design (N=88 enrolled; 87 treated in the safety population).
Administered intravenous pembrolizumab (200 mg every 3 weeks for up to 35 cycles) plus 5 scheduled subcutaneous doses of PDS0101 to ICI-naive (n=53, CPS ≥ 1) and ICI-resistant (n=22) cohorts in the modified intent-to-treat population (N=75).
In the ICI-naive cohort (n=53), the central reviewer objective response rate was 34.0%, median progression-free survival was 5.3 months (95% CI, 2.10-9.00), and median overall survival was 39.3 months (95% CI, 23.90 to not evaluable).
In the ICI-resistant cohort (n=22), the primary endpoint was not met with an objective response rate of 0% and a median overall survival of 14.8 months (95% CI, 8.50-26.00).
The combination regimen was well tolerated, with grade 3 or higher treatment-related adverse events occurring in 13.8% of participants.

Cite This Study

Weiss et al. (2026) studied this question.

synapsesocial.com/papers/6aad0b72de0393d728b89cd6 https://doi.org/10.1001/jamaoncol.2026.3492

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Implication

Randomized trial reveals robust antitumor activity with PDS0101 and pembrolizumab in untreated HPV16-positive head and neck cancer, suggesting significant clinical benefit in first-line therapy.

PDS0101 With Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Discussion

Member takes

Implication

Key Points

Cite This Study

PDS0101 With Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Discussion

Member takes

Implication

Key Points

Cite This Study

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