Abstract
Background: ASP-1929 photoimmunotherapy—cetuximab conjugated to IRDye 700DX and red light (690 nm) for localized drug activation—results in rapid, selective cell killing.
Methods: This phase Ib/II open-label study evaluated ASP-1929 photoimmunotherapy plus pembrolizumab in patients with recurrent/metastatic HNSCC (≥ 1 accessible lesion, PD-L1 combined positive score ≥ 1, ineligible for standard locoregional ther- apy). Primary objectives were safety/tolerability and objective response rate (ORR). Secondary objectives included overall sur- vival (OS) and progression-free survival (PFS).
Results: Eighteen patients (median age 63 years, 74% male) comprised the photoimmunotherapy-evaluable population. The confirmed ORR was 27.8% (95% CI 9.7–53.5); four of five responders had complete responses (95% CI, 6.4–47.6). Median OS was 25.6 months (95% CI, 14.6–not evaluable); median PFS was 2.9 months (95% CI, 1.4–14.6). The most common serious adverse reactions were dysphagia and tongue edema (each n = 2; 10.5%).
Conclusions: ASP-1929 photoimmunotherapy plus pembrolizumab was generally tolerable, with promising efficacy in patients with recurrent/metastatic HNSCC.
Document Type
Article
Publication Date
2026
Digital Object Identifier (DOI)
https://doi.org/10.1002/hed.70014
Funding Information
This work was supported by Rakuten Medical.
Repository Citation
Cognetti, David M.; Curry, Joseph M.; Johnson, Jennifer; Kwon, Michael; Su, Shirley Y.; Civantos, Francisco; Olazagasti, Coral; Valentino, Joseph; Arnold, Susanne; Bell, R. Bryan; Gibson, Michael K.; Mannion, Kyle; Van Abel, Kathryn M.; Price, Katharine A.; Dong, Haiying; Thorne, Amy H.; Suzuki, Toshiaki; and Gillenwater, Ann M., "Safety and Efficacy Findings From a Phase Ib/II Study of ASP-1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma" (2026). Otolaryngology--Head & Neck Surgery Faculty Publications. 22.
https://uknowledge.uky.edu/otolaryngology_facpub/22
Notes/Citation Information
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2025 The Author(s). Head & Neck published by Wiley Periodicals LLC.