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Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L HPV-negative R/M HNSCC at ESMO Asia 2025
Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates overall response rate and safety profile consistent with the 1500mg QW dose Data
About this update from Bicara Therapeutics Inc.
[{"type":"text","content":"Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates overall response rate and safety profile consistent with the 1500mg QW dose Data inform and advance progress toward dose selection for ongoing pivotal FORTIFI-HN01 clinical trial of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Company to host conference call and webcast on Saturday, December 6, 2025 at 9:00 a.m. ET BOSTON, Dec. 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 announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast on Saturday, December 6, at 9:00 a.m. ET. “The preliminary data for 750mg of ficerafusp alfa are encouraging, with a consistently high overall response rate now observed across both dose levels of ficerafusp alfa under evaluation for the optimal biologic dose for our ongoing, pivotal FORTIFI-HN01 study,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “Importantly, these results provide valuable context around the safety and efficacy profile of ficerafusp alfa in patients with HPV-negative head and neck squamous cell carcinoma and were used to support our FDA Breakthrough Therapy Designation. The consistent overall response rate across both doses of ficerafusp alfa reinforces our confidence that the interim analysis in the pivotal trial could support accelerated approval.” Presentation Details Title: Ficerafusp alfa 750 mg QW and pembrolizumab in HPV-negative first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)Abstract #: 6670Session Name: Proffered Paper session: Head and neck cancerPresentation Date and Time: Saturday, December 6, 2025, 4:50 – 5:00 p.m. SGT / 3:50 – 4:00 a.m. EST Presenter: Deborah J. Wong, MD, PhD, Director of the Head and Neck Medical...