{"entity":{"id":"ficerafusp-alfa","kind":"drug","name":"Ficerafusp alfa","aka":[],"tldr":"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.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"JCO 2025 two-year results","url":"https://ascopubs.org/doi/10.1200/JCO-25-02027"}],"tags":[],"related":[],"cancers":["head-and-neck","recurrent-metastatic-hnscc","hpv-negative-head-and-neck-cancer"],"sections":[],"technologies":["bispecific-antibody"],"targets":["egfr"],"drugs":["pembrolizumab"],"companies":["bicara-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["fortifi-hn01","nct07807163"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","approvals":[],"mechanismSteps":["Binds EGFR on tumour cells, localising the molecule to the tumour","The TGF-βRII trap sequesters TGF-β in the microenvironment","Fibroblast activation and T-cell exclusion decrease; PD-1 blockade then acts on infiltrating T cells"],"dosing":{"route":"Intravenous","schedule":"1500 mg every 2 weeks with pembrolizumab","source":"https://clinicaltrials.gov/study/NCT06788990"},"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ficerafusp-alfa/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-negative-head-and-neck-cancer","kind":"cancer","name":"HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)","route":"/cancers/hpv-negative-head-and-neck-cancer/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"bicara-therapeutics","kind":"company","name":"Bicara Therapeutics","route":"/companies/bicara-therapeutics/"}],"trial":[{"id":"nct07807163","kind":"trial","name":"A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC","route":"/trials/nct07807163/"},{"id":"fortifi-hn01","kind":"trial","name":"FORTIFI-HN01","route":"/trials/fortifi-hn01/"}],"pairing":[{"id":"egfr-bispecific-plus-pd1-hnscc","kind":"pairing","name":"EGFR-directed bispecific + PD-1 blockade","route":"/pairings/egfr-bispecific-plus-pd1-hnscc/"}]}}