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Section editor transclusions Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated AML, please see the main AML page for other regimens.
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IDH1 first-line therapy, older or 'unfit' patients
Azacitidine monotherapy
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Montesinos et al. 2022 (AGILE) | 2018-2021 | Phase 3 (C) | Azacitidine & Ivosidenib | Inferior OS |
Biomarker eligibility criteria
- IDH1 mutation
References
- AGILE: Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, Heuser M, Calado RT, Schuh AC, Yeh SP, Daigle SR, Hui J, Pandya SS, Gianolio DA, de Botton S, Döhner H. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022 Apr 21;386(16):1519-1531. link to original article contains dosing details in abstract PubMed NCT03173248
Azacitidine & Ivosidenib
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Montesinos et al. 2022 (AGILE) | 2018-2021 | Phase 3 (E-RT-esc) | Azacitidine | Superior OS Median OS: 24 vs 7.9 mo (HR 0.44, 95% CI 0.27-0.73) |
Biomarker eligibility criteria
- IDH1 mutation
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 7
Targeted therapy
- Ivosidenib (Tibsovo) 500 mg PO once per day
28-day cycles
References
- AGILE: Montesinos P, Recher C, Vives S, Zarzycka E, Wang J, Bertani G, Heuser M, Calado RT, Schuh AC, Yeh SP, Daigle SR, Hui J, Pandya SS, Gianolio DA, de Botton S, Döhner H. Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia. N Engl J Med. 2022 Apr 21;386(16):1519-1531. link to original article contains dosing details in abstract PubMed NCT03173248
Ivosidenib monotherapy
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Roboz et al. 2019 (AG120-C-001) | 2014-2017 | Phase 1/2 (RT) |
Biomarker eligibility criteria
- Gene: IDH1
- Alteration: R132
References
- AG120-C-001: Roboz GJ, DiNardo CD, Stein EM, de Botton S, Mims AS, Prince GT, Altman JK, Arellano ML, Donnellan WB, Erba HP, Mannis GN, Pollyea DA, Stein AS, Uy GL, Watts JM, Fathi AT, Kantarjian HM, Tallman MS, Choe S, Dai D, Fan B, Wang H, Zhang V, Yen KE, Kapsalis SM, Hickman D, Liu H, Agresta SV, Wu B, Attar EC, Stone RM. Ivosidenib induces deep durable remissions in patients with newly diagnosed IDH1-mutant acute myeloid leukemia. Blood. 2020 Feb 13;135(7):463-471. Epub 2019 Dec 16. link to original article link to PMC article PubMed NCT02074839
- HOVON 150 AML: NCT03839771
IDH1 relapsed or refractory, salvage therapy
Ivosidenib monotherapy
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| DiNardo et al. 2018 (AG120-C-001) | 2014-2017 | Phase 1/2 (RT) | ORR: 42% |
Biomarker eligibility criteria
- Alteration: IDH1 R132 gene variant
References
- AG120-C-001: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. link to original article contains dosing details in abstract PubMed NCT02074839
Olutasidenib monotherapy
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Watts et al. 2022 (2102-HEM-101) | 2016-2018 | Phase 1/2 (RT) | CR+CRh rate: 35% |
Biomarker eligibility criteria
- Alteration: IDH1 R132 gene variant
References
- 2102-HEM-101: Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, Pigneux A, Montesinos P, Wang ES, Seiter KP, Wei AH, De Botton S, Arnan M, Donnellan W, Schwarer AP, Récher C, Jonas BA, Ferrell PB Jr, Marzac C, Kelly P, Sweeney J, Forsyth S, Guichard SM, Brevard J, Henrick P, Mohamed H, Cortes JE. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2022 Nov 9:S2352-3026(22)00292-7. Epub ahead of print. link to original article PubMed NCT02719574
IDH2 first-line therapy, older or 'unfit' patients
Enasidenib monotherapy
Regimen
| Study | Years of enrollment | Evidence |
|---|---|---|
| Pollyea et al. 2019 (AG-221-C-001 untreated) | 2013-NR | Phase 1/2 |
Biomarker eligibility criteria
- Alteration: IDH2 gene variant
References
- AG-221-C-001 untreated: Pollyea DA, Tallman MS, de Botton S, Kantarjian HM, Collins R, Stein AS, Frattini MG, Xu Q, Tosolini A, See WL, MacBeth KJ, Agresta SV, Attar EC, DiNardo CD, Stein EM. Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia. Leukemia. 2019 Nov;33(11):2575-2584. Epub 2019 Apr 9. link to original article Pubmed NCT01915498
IDH2 Relapsed or refractory, salvage therapy
Enasidenib monotherapy
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Stein et al. 2017 (AG-221-C-001 relapsed) | 2013-2016 | Phase 1/2 (RT) | ORR: 40% |
This is the dose used in the phase 2 expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.
Biomarker eligibility criteria
- Alteration: IDH2 gene variant
References
- AG-221-C-001 relapsed: Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, Stone RM, DeAngelo DJ, Levine RL, Flinn IW, Kantarjian HM, Collins R, Patel MR, Frankel AE, Stein A, Sekeres MA, Swords RT, Medeiros BC, Willekens C, Vyas P, Tosolini A, Xu Q, Knight RD, Yen KE, Agresta S, de Botton S, Tallman MS. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731. Epub 2017 Jun 6. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01915498