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.

Authors

• David M Cognetti
• Joseph M Curry
• Jennifer Johnson
• Michael Kwon
• Shirley Y Su
• Francisco Civantos
• Coral Olazagasti
• Joseph Valentino
• Susanne M Arnold
• R Bryan Bell
• Michael K Gibson
• Kyle Mannion
• Kathryn M Van Abel
• Katharine A Price
• Haiying Dong
• Amy H Thorne
• Toshiaki Suzuki
• Ann M Gillenwater

Publication/Presentation Date

1-1-2026

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.

Volume

48

Issue

1

First Page

160

Last Page

174

ISSN

1097-0347

Published In/Presented At

Cognetti, D. M., Curry, J. M., Johnson, J., Kwon, M., Su, S. Y., Civantos, F., Olazagasti, C., Valentino, J., Arnold, S. M., Bell, R. B., Gibson, M. K., Mannion, K., Van Abel, K. M., Price, K. A., Dong, H., Thorne, A. H., Suzuki, T., & Gillenwater, A. M. (2026). 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. Head & neck, 48(1), 160–174. https://doi.org/10.1002/hed.70014

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

40852760

Department(s)

Administration and Leadership

Document Type

Article