Drug intelligence / Profile preview

ONO-4578 + nivolumab + chemotherapy

Development stage
Unknown
Lead developer
Ono Pharmaceutical
Modality
Nucleic Acid-Directed Small Molecules → Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Covalent Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Oral (ONO-4578), Intravenous (nivolumab, Oxaliplatin), Oral (capecitabine, S-1)
01

Overview

ONO-4578 + nivolumab + chemotherapy is a combination therapy under clinical investigation, primarily for the treatment of HER2-negative unresectable advanced or recurrent gastric cancer, including esophagogastric junction cancer. **ONO-4578** is a selective small-molecule antagonist of the prostaglandin E2 receptor EP4, which is implicated in tumor immunosuppression. **Nivolumab** is a monoclonal antibody acting as a programmed death-1 (PD-1) immune checkpoint inhibitor, used to promote anti-tumor immune responses. The chemotherapy components (capecitabine, oxaliplatin, or S-1) are antineoplastic agents commonly used to treat gastrointestinal cancers. This combination aims to enhance anti-tumor immunity by inhibiting EP4-mediated immunosuppression and PD-1-dependent immune checkpoint signaling alongside direct cytotoxic effects of chemotherapy[1][2][5][7].

Other names
nivolumabchemotherapy (as a regimen, not a specific product)ONO-4578 + nivolumab + capecitabine + oxaliplatin (as in clinical trial context)ONO-4578 + nivolumab + S-1 + oxaliplatin (as in clinical trial context)
02

Targets

TS (Thymidylate synthase)PTGER4 (Prostaglandin E2 receptor EP4 subtype)DNAPDCD1 (Programmed cell death protein 1 receptor)

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