Olutasidenib monotherapy (Study 2102-HEM-101) — R/R AML with susceptible IDH1 mutation
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-OLUTASIDENIB |
|---|
| ID | REG-OLUTASIDENIB-AML-RR-IDH1 |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| 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.
Used By
Indication
IND-AML-RR-IDH1-OLUTASIDENIB- IND-AML-RR-IDH1-OLUTASIDENIB