Bicara Therapeutics has selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in its Phase 3 FORTIFI-HN01 study. The company expects substantial enrollment in the pivotal trial by the end of 2026, positioning the program for an interim analysis in mid-2027.

Ficerafusp alfa is the first bifunctional epidermal growth factor receptor (EGFR)-directed antibody combined with a TGF-β ligand trap, designed to improve tumor penetration and enhance survival outcomes. Bicara is also planning multiple expansion cohort data readouts in 2026 to better characterize the therapy’s profile in HPV-negative HNSCC and explore its potential in other solid tumors, including colorectal cancer.

Claire Mazumdar, chief executive officer at Bicara Therapeutics, said: “Bicara is entering 2026 with strong momentum and a clear plan for growth as we advance ficerafusp alfa, designed to generate significantly improved clinical outcomes in head and neck cancer that we believe will translate to commercial success. We are thrilled to announce that we have selected 1500 mg of ficerafusp alfa as the optimal dose for Phase 3 of the FORTIFI-HN01 pivotal study. Our focus for 2026 is to accelerate enrollment and end the year with a clear line of sight to an interim analysis in mid-2027.”

The company has aligned with the FDA on a clear path to implement the optimal Phase 3 dosing by the end of the first quarter. Bicara has also initiated strategic preparations for a commercial launch in HPV-negative HNSCC, a biologically distinct disease marked by immune exclusion and a challenging tumor microenvironment. The majority of patients rapidly develop therapeutic resistance, highlighting the need for more effective and durable treatment options.

Ficerafusp alfa has shown clinical data that more than doubles median overall survival compared to standard of care and improves median duration of response compared with other pembrolizumab combinations and EGFR-targeting agents. With increased confidence in the therapy’s clinical potential, Bicara plans to make key commercial hires in 2026, including a chief commercial officer, to prepare for launch readiness.

The bifunctional approach of ficerafusp alfa targets EGFR-expressing tumor cells while modulating TGF-β signaling in the tumor microenvironment. This dual action is intended to improve tumor accessibility and support deeper, more durable anti-tumor responses when combined with immune checkpoint inhibitors. Bicara is also evaluating ficerafusp alfa in metastatic colorectal cancer and plans further signal-finding studies in other solid tumors where EGFR and TGF-β biology are implicated.

Claire Mazumdar added: “Our goal is to ensure that we are best positioned to achieve ficerafusp alfa’s potential, while advancing other signal-finding efforts that are based upon clear biologic and mechanistic rationale to better characterize ficerafusp alfa’s pipeline-in-a-product potential.”

Key milestones for 2026 include presenting data from an exploratory Phase 1b expansion cohort evaluating 2000 mg of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC in the first quarter, releasing long-term follow-up data from Phase 1b in the second quarter, achieving substantial Phase 3 enrollment by year-end, and advancing commercial hires and organizational preparation for launch readiness. Additional Phase 1b expansion cohort data for metastatic colorectal cancer patients is also expected in the second half of 2026.