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simlukafusp alfa + cetuximab

Development stage: Unknown
Lead developer: Roche
Modality: Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration: Intravenous

Overview

Simlukafusp alfa + cetuximab is a combination therapy comprising simlukafusp alfa (FAP-IL2v, RG-7461), a fibroblast activation protein-alpha (FAP)-targeted interleukin-2 variant (IL2v) immunocytokine, and cetuximab, an EGFR-targeting monoclonal antibody. Simlukafusp alfa is engineered to selectively activate immune responses within the tumor microenvironment by engaging FAP-overexpressing stromal cells and expanding intratumoral NK and CD8 T cells, while minimizing CD25-mediated toxicity. Cetuximab binds to the epidermal growth factor receptor (EGFR), blocking ligand-induced signaling and promoting antibody-dependent cellular cytotoxicity (ADCC). The combination was investigated for recurrent, unresectable, or metastatic head and neck squamous cell carcinoma (HNSCC); while it showed pharmacodynamic activity, overall antitumor efficacy was limited.

Other names: simlukafusp alfa + cetuximabFAP-IL2v + cetuximabRG-7461 + cetuximab

Targets

IL2RA (Interleukin-2 receptor alpha subunit)EGFR (Epidermal growth factor receptor)IL2RB (IL-2 receptor beta chain)FAP (Fibroblast activation protein alpha)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)

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