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.

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 com

SUBMITTER: Cognetti DM 

PROVIDER: S-EPMC12703558 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature