Drug intelligence / Profile preview

ivosidenib + capecitabine

Development stage
Phase 3
Lead developer
Servier
Modality
Small Molecules
Administration
Oral
01

Overview

Ivosidenib + capecitabine is a combination regimen being evaluated in the adjuvant setting for patients with resected biliary tract cancer (BTC) harboring IDH1 mutations. **Ivosidenib** is an oral small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme, which is responsible for the production of the oncometabolite 2-hydroxyglutarate (2-HG). By inhibiting mutant IDH1, ivosidenib restores normal cellular differentiation and inhibits tumor cell proliferation. **Capecitabine** is an oral fluoropyrimidine carbamate that acts as a systemic prodrug of 5-fluorouracil (5-FU). It is converted to 5-FU within the tumor by thymidine phosphorylase, where it subsequently inhibits DNA synthesis and slows tumor growth. This combination is specifically being tested in the **SAFIR-IMPACT BTC** phase 3 umbrella trial, sponsored by **Unicancer**, to determine if matched targeted therapy is superior to standard-of-care adjuvant chemotherapy in preventing cancer recurrence after surgical resection.

Other names
ivosidenib and capecitabine
02

Targets

CYP2C8 (Cytochrome P450 2C8)SLC22A8 (Organic anion transporter 3)TS (Thymidylate synthase)DNAIDH1 (Isocitrate dehydrogenase [NADP] cytoplasmic)

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