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Bicara Therapeutics Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025
Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median
About this update from Bicara Therapeutics Inc.
[{"type":"text","content":"Median DOR of 21.7 months with 80% of responders achieving a deep response (≥80% tumor shrinkage) Depth and durability translating to prolonged OS with median OS of 21.3 months and 2-year OS of 46% in HPV-negative HNSCC Conference call and webcast today at 3:00 p.m. CT / 4:00 p.m. ET BOSTON, June 01, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today presented updated data from the company’s Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). “Ficerafusp alfa was specifically designed to impact the tumor stroma and drive tumor penetration with the goal of leading to deeper and more durable responses. We’ve now begun to see this translate clinically, with responses lasting nearly two years and contributing to prolonged overall survival in HPV-negative patients, a population that typically faces poor outcomes due to resistance to available therapies,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “The strength of the totality of this updated dataset, including 80% of responders achieving a deep response of at least 80% tumor shrinkage, median duration of response of 21.7 months, median progression free survival of 9.9 months, overall survival of 21.3 months, and a 2-year overall survival rate of 46%, provides compelling support for the continued advancement of FORTIFI-HN01, our pivotal Phase 2/3 trial in the first-line recurrent/metastatic setting.” Key highlights from the presentation include: In the Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab resulted in deep and durable anti-tumor activity with improve...