At a median follow-up of three years, 1500mg of ficerafusp alfa weekly in combination with pembrolizumab demonstrated an estimated 31% overall survival, approximately doubling OS compared to a retrospective analysis of standard of care

Phase 1b dataset of ~90 patients in 1L R/M HPV-negative HNSCC across all three doses demonstrated that deep responses translated into durable long-term outcomes across DOR, PFS, and OS, with a generally well-tolerated safety profile and no new safety signals

Pooled analyses reinforced the TGF-β contribution and demonstrated that deep responders have greater durability of response and appeared more likely to remain progression-free and alive

Company to host conference call and webcast on Friday, May 22, 2026 at 8:30 a.m. ET

BOSTON, May 21, 2026 (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 extended follow-up data out to three years from the Phase 1/1b study of ficerafusp alfa in combination with pembrolizumab in first-line (1L) recurrent/metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). The data, which included the 750mg weekly (QW), 1500mg QW, and 2000mg every-other-week (Q2W) expansion cohorts, demonstrated deep, durable responses observed to be driven by TGF-β inhibition. The data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Ficerafusp alfa is a bifunctional epidermal growth factor receptor (EGFR)-directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap designed to enable increased tumor penetration to drive deep and durable responses and potentially improve survival outcomes. Bicara is currently evaluating ficerafusp alfa at 1500mg QW in combination with pembrolizumab in the Phase 3 portion of the ongoing FORTIFI-HN01 pivotal study. Additionally, the company plans to initiate a study evaluating a 12-week loading dose followed by a 2250mg every-three-weeks maintenance dose regimen in the third quarter of 2026 to support long-term administration.