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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.
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.
Anti-EGFR IgG1 with a TGF-βRII extracellular domain fused to the heavy chain, neutralising TGF-β locally. Connects to EGFR.
1.Binds EGFR on tumour cells, localising the molecule to the tumour
Source: clinicaltrials.gov/study/NCT06788990. Doses are for orientation; the current label governs.
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Query for this drug: (TITLE:"Ficerafusp alfa" OR ABSTRACT:"Ficerafusp alfa" OR TITLE:"BCA101" OR ABSTRACT:"BCA101") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ficerafusp alfa, not a curated reading list.
Shares EGFR-directed bispecific + PD-1 blockade, Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies, EGFR.
Shares EGFR-directed bispecific + PD-1 blockade, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, Head and neck squamous cell carcinoma.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, EGFR, Head and neck squamous cell carcinoma.
Shares Recurrent or metastatic head and neck squamous cell carcinoma, Head and neck squamous cell carcinoma, Pembrolizumab.
Shares HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Recurrent or metastatic head and neck squamous cell carcinoma, EGFR, Head and neck squamous cell carcinoma.
Shares Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies, Head and neck squamous cell carcinoma.
Shares Recurrent or metastatic head and neck squamous cell carcinoma, Bispecific antibodies, Head and neck squamous cell carcinoma, Pembrolizumab.