# Ficerafusp alfa

Source: https://onco.cc/drugs/ficerafusp-alfa/  
OnCo record `ficerafusp-alfa` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ficerafusp alfa is an EGFR antibody fused to a TGF-beta sponge, designed to remove the immune-suppressing signal that keeps HPV-negative throat cancers cold.

## Summary

Ficerafusp alfa (Bicara Therapeutics) is a bifunctional antibody: an anti-EGFR IgG1 with the extracellular domain of TGF-beta receptor II fused to its heavy chain, so it blocks EGFR on tumour cells and neutralises TGF-beta locally, removing an immune-suppressing signal that keeps HPV-negative head and neck tumours cold. It is given at 1500 mg every 2 weeks with pembrolizumab in first-line HPV-negative head and neck squamous cell carcinoma. A phase 1/1b study with pembrolizumab showed durable responses at two years (JCO 2025). The FORTIFI-HN01 phase 2/3 trial fixed the dose at 1500 mg, excludes HPV-positive oropharyngeal cancer, and expects an interim analysis in mid-2027. Whether trapping TGF-beta adds meaningfully to EGFR and PD-1 blockade in a randomised setting is the open question. For a newcomer, it is an EGFR antibody fused to a TGF-beta sponge.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Code: BCA101
- Modality: Bifunctional antibody (EGFR × TGF-β trap)
- Mechanism: Anti-EGFR IgG1 with a TGF-βRII extracellular domain fused to the heavy chain, neutralising TGF-β locally.
- Dosing: Intravenous; 1500 mg every 2 weeks with pembrolizumab

## Sources

- JCO 2025 two-year results: https://ascopubs.org/doi/10.1200/JCO-25-02027

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Bicara Therapeutics](https://onco.cc/companies/bicara-therapeutics/)
- trials: [A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC](https://onco.cc/trials/nct07807163/), [FORTIFI-HN01](https://onco.cc/trials/fortifi-hn01/)
- pairings: [EGFR-directed bispecific + PD-1 blockade](https://onco.cc/pairings/egfr-bispecific-plus-pd1-hnscc/)

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