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Cue Biopharma Presents Positive Data Update from Ongoing Phase 1 Trials of CUE-101 for Recurrent/Metastatic HPV+ Head and Neck Squamous Cell Carcinoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

As of the data cutoff date, nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five

articleCue Biopharma, Inc.May 25, 20233/company/cue-biopharma/news/cue-biopharma-presents-positive-data-update-from-ongoing-phase-1-trials-of-cue-101-for-recurrentmetastatic-hpv-head-and-neck-squamous-cell-carcinoma-at-the-2023-american-society-of-clinical-oncology-asco-annual-meeting
Cue Biopharma Presents Positive Data Update from Ongoing Phase 1 Trials of CUE-101 for Recurrent/Metastatic HPV+ Head and Neck Squamous Cell Carcinoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

About this update from Cue Biopharma, Inc.

[{"type":"text","content":"As of the data cutoff date, nine of the 14 evaluable patients treated with CUE-101+ KEYTRUDA® (pembrolizumab) demonstrated tumor regression, with five confirmed partial responses (PRs) and three durable stable disease (DSD) responses, two of which have tumor burden reductions of -18% and -24% and remain on treatment100% of patients treated with CUE-101+ pembrolizumab at the recommended phase 2 dose (RP2D) of 4mg/kg (n=16) remain alive to date following treatment As of the data cutoff date, CUE-101 as monotherapy at the RP2D of 4mg/kg demonstrated median overall survival (mOS) approaching 14 months, in third line and beyond (3L+) patients, ~6 months longer than reported with current standard of care in second line (2L) patients Clinical data supports potential registrational paths for both CUE-101 as a monotherapy in 3L+ R/M HPV16+ HNSCC, and CUE-101+ pembrolizumab in first line (1L) R/M HPV16+ HNSCC BOSTON, May 25, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, announced today the presentation of a positive data update from its ongoing Phase 1 clinical trials evaluating its lead biologic from the IL-2-based CUE-100 series, CUE-101, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab. The data will be presented in a poster by Dr. Christine Chung, M.D., Chair, Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center on June 5, 2023 at the ASCO Annual Meeting in Chicago, IL. In addition, the poster will also be highlighted by an expert head and neck cancer panel during a Poster Discussion Session immediately following the scheduled poster presentation. “CUE-101 clinical data to date continues to demonstrate both promising evidence of single-agent activity as well as complementary activity in combination with checkpoint inhibitor pembrolizumab.” said Matteo Levisetti, M.D., chief medical officer of Cue Biopharma. “Based on the strength of the data to date, we believe CUE-101 has the promise to be a potential therapeutic advancement for patients battling head and neck cancer, a devastat...

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