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

Abstract

Key Points Question Does adding PDS0101 to pembrolizumab demonstrate antitumor activity and tolerability in patients with recurrent/metastatic human papillomavirus type 16–positive head and neck squamous cell carcinoma who are immune checkpoint inhibitor (ICI)–naive or ICI-resistant? Findings In this nonrandomized clinical trial of 88 patients with head and neck squamous cell carcinoma, among the 53 ICI-naive participants in the modified intent-to-treat population, the response rate was 34%, 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 response rate was 0%, median progession-free survival was 2 months, and median overal survival was 14.8 months. Meaning The trial results suggest that PDS0101 plus pembrolizumab demonstrated antitumor activity with manageable safety in ICI-naive participants, supporting further evaluation.