공시 • May 24
Bicara Therapeutics Inc Announces Extended Follow-Up Data for Ficerafusp Alfa Plus Pembrolizumab in Head and Neck Squamous Cell Carcinoma
Bicara Therapeutics Inc. 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 recurrent/metastatic human papillomavirus-negative head and neck squamous cell carcinoma. The data, which included the 750mg weekly, 1500mg weekly, and 2000mg every-other-week expansion cohorts, demonstrated deep, durable responses observed to be driven by TGF-ß inhibition. Ficerafusp alfa is a bifunctional epidermal growth factor receptor-directed monoclonal antibody bound to a human transforming growth factor beta 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 weekly 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. 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 approximately 90 patients in first-line recurrent/metastatic HPV-negative head and neck squamous cell carcinoma across all three doses demonstrated that deep responses translated into durable long-term outcomes across duration of response, progression-free survival, and overall survival, with a generally well-tolerated safety profile and no new safety signals. Pooled analyses reinforced the TGF-ß contribution and demonstrated that deep responders have greater durability of response and appeared more likely to remain progression-free and alive. Across all dose cohorts of ficerafusp alfa in combination with pembrolizumab, the data demonstrated deep, durable responses and a generally well-tolerated safety profile. All three dose cohorts also demonstrated clinically meaningful duration of response, progression-free survival and overall survival, representing substantial improvements over standard of care treatment. Notably, complete response rates have continued to mature across all three cohorts since prior data presentation - increasing to 13% at 750mg weekly, 25% at 1500mg weekly, and 30% at 2000mg every-other-week as of the March 31, 2026 data snapshot. Additionally, deep responses of at least 80% tumor shrinkage were observed at doses of ficerafusp alfa that resulted in greater TGF-ß inhibition and tumor penetration, with more than three-fourths of responders in the 1500mg weekly and 2000mg every-other-week cohorts achieving deep responses. Three-year follow-up from the 1500mg weekly dose cohort, as of the March 31, 2026 data snapshot, showed an estimated overall survival rate of 31%, approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients. Table 1. Key Efficacy Results Across Ficerafusp Alfa Dose Cohorts in Combination with Pembrolizumab in First-Line Recurrent/Metastatic HPV-Negative Head and Neck Squamous Cell Carcinoma: 750mg weekly (n=30): Confirmed overall response rate 57%, complete response rate 13%, deep (=80%) responses 47%, median time to response 1.6 months, median duration of response not reached (>16.6 months), median progression-free survival 6.9 months, median overall survival not mature (>19.4 months); 1500mg weekly (n=28): Confirmed overall response rate 54%, complete response rate 25%, deep (=80%) responses 80%, median time to response 1.4 months, median duration of response 21.7 months, median progression-free survival 9.9 months, median overall survival 21.3 months; 2000mg every-other-week (n=27): Confirmed overall response rate 48%, complete response rate 30%, deep (=80%) responses 77%, median time to response 1.6 months, median duration of response not reached (>12.8 months), median progression-free survival 12.7 months, median overall survival not mature (>12.7 months; >23.6 months in patients with > 2-year follow-up). Data snapshot as of March 31, 2026. Not reached = not reached; not mature = not mature. Data maturation reflects a bimodal enrollment distribution: in the initial 15 efficacy evaluable patients (median follow-up: 27 months) median overall survival is not mature but has surpassed 23.6 months. The remaining 12 efficacy evaluable patients had a median follow-up of 11.7 months. Biomarker analyses across all three dose cohorts demonstrated sustained TGF-ß inhibition and immune activation with ficerafusp alfa, reinforcing the mechanistic link between intra-tumoral TGF-ß inhibition, immune activation, and the deep, durable responses. Ficerafusp alfa’s depth of response, as demonstrated by complete response rates and proportion of deep responders, has been well-established and is clinically differentiating.