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

JAMA Oncology 10.1001/jamaoncol.2026.3492

September 17, 2026 at 11:00 AM EDT

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The results of this nonrandomized clinical trial suggest that PDS0101 plus pembrolizumab showed antitumor activity in ICI-naive HPV16-positive R/M HNSCC, with favorable safety, response rates, and survival outcomes. The findings support further evaluation in a first-line setting.

Corresponding Author: Jared Weiss, MD, The University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, 170 Manning Dr, Room 3115, Chapel Hill, NC 27514 (jared_weiss@med.unc.edu).

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