Drug intelligence / Profile preview

ivosidenib + durvalumab + gemcitabine + cisplatin

Development stage
Unknown
Lead developer
Servier
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, Intravenous
01

Overview

This investigational combination therapy is a multi-modal regimen being evaluated for the first-line treatment of patients with locally advanced, unresectable, or metastatic cholangiocarcinoma harboring IDH1 mutations. The regimen consists of four distinct components: **ivosidenib**, a small molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1) that reduces the production of the oncometabolite 2-hydroxyglutarate (2-HG); **durvalumab**, a monoclonal antibody that blocks programmed cell death ligand 1 (PD-L1) to enhance anti-tumor immune responses; and the cytotoxic chemotherapy doublet of **gemcitabine** and **cisplatin**. By combining targeted therapy, immune checkpoint blockade, and standard-of-care chemotherapy, the treatment aims to simultaneously inhibit oncogenic metabolic signaling, restore T-cell activity, and induce DNA damage in cancer cells. The therapy is currently being investigated in Phase 1b/2 clinical trials sponsored by Servier and its subsidiary Symphogen.

Other names
ivosidenib + durvalumab + gemcitabine + cisplatinivosidenib + durvalumab + gemcitabine/cisplatine
02

Targets

RNR (Ribonucleotide reductase)IDH1 (Isocitrate dehydrogenase [NADP] cytoplasmic)DNA polymerase familyDNACD274 (Programmed cell death protein 1 ligand 1)

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