Olutasidenib monotherapy (Study 2102-HEM-101) — R/R AML with susceptible IDH1 mutation
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.
| Composantes | DRUG-OLUTASIDENIB |
|---|
| ID | REG-OLUTASIDENIB-AML-RR-IDH1 |
|---|---|
| Type | Protocole thérapeutique |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| Sources | SRC-ESMO-AML-2020 SRC-NCCN-AML-2025 |
Notes
Study 2102-HEM-101 (de Botton Blood 2023; Cortes EHA 2022) phase 1/2, single-arm: olutasidenib 150 mg PO BID continuous, in relapsed / refractory AML with IDH1 R132 mutation (n=153 R/R AML efficacy cohort). CR + CRh rate 35% (95% CI 27-43); among CR + CRh responders, median DoR 25.9 mo, median time to CR + CRh 1.9 mo, 56-day mortality 8%. Transfusion independence achieved in 56% of baseline-dependent patients. FDA accelerated approval Dec 2022. Mechanistically: olutasidenib is a more selective mutant-IDH1 inhibitor than ivosidenib (in vitro selectivity for mIDH1 R132 variants over WT-IDH1 / IDH2). Differentiation syndrome incidence ~14% (similar to ivosidenib); hepatotoxicity boxed warning is distinguishing feature vs ivosidenib (no boxed warning). QTc prolongation less frequent than ivosidenib in cross-trial. STUB pending Clinical Co-Lead sign-off. Trial source SRC-OLUTASIDENIB-DEBOTTON-2023 is available as a bibliographic record; cited via NCCN-AML-2025 + ESMO-AML-2020.
Utilisé par
Indication
IND-AML-RR-IDH1-OLUTASIDENIB- IND-AML-RR-IDH1-OLUTASIDENIB