Citations 1
Safety and Efficacy Findings From a Phase Ib/ II Study of ASP ‐1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squ
Cognetti, David M. , Johnson, Jennifer M. , Kwon, Michael , Su, Shirley Y. , Civantos, Francisco , Valentino, Joseph, Bell, R. Bryan, Abel, Kathryn M. Van , Price, Katharine A. , Dong, Haiying, Thorne, Amy Haseley, Van Abel, Kathryn M , Su, Shirley Y , Curry, Joseph , Olazagasti, Coral , Arnold, Susanne M. , Gibson, Michael K. , Mannion, Kyle , Suzuki, Toshiaki , Gillenwater, Ann Marie
Head & Neck | August 25, 2025 | Volume: 48 | Issue: 1 | Pages: 160-174
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 therapy). Primary objectives were safety/tolerability and objective response rate (ORR). Secondary objectives included overall survival (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.