Cue Biopharma Issues Update On Its Clinical Stage Asset, CUE-101, Representative Of CUE-100 Series; Data Highlights Include ORR Of 50% In Treatment-Naive Patients With HPV+ R/M HNSCC

ORR of 50% in treatment-naïve patients with HPV+ R/M HNSCC

12-month landmark survival of 88% and mOS of 32 months

BOSTON, July 01, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series.

Dr. Dimitrios Colevas presented new data from the company's maturing Phase 1 trial evaluating CUE-101 in combination with KEYTRUDA® (pembrolizumab) for patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of 50% (with 1 unconfirmed PR) in patients with combined positive score (CPS) >1 and an ORR of 50% observed in patients with low CPS scores (1-19). This compares favorably to the historical ORR of 19% observed with pembrolizumab alone in the third-party KEYNOTE 048 trial. Notably, the 12-month overall survival (OS) of 88% in the Phase 1 trial represents a significant reduction in the risk of death (HR 0.23) compared to historical data from the KEYNOTE 048 study. The Kaplan-Meier (K-M) estimate for median overall survival (mOS) is currently 32 months.