Acute myeloid leukemia, IDH-mutated

From HemOnc.org - A Hematology Oncology Wiki
Jump to: navigation, search
Page editor
MartinSchoen.jpg
Martin Schoen, MD, MPH
St. Louis, MO

Note: these are biomarker-specific regimens for patients with IDH-mutated AML, please see the main AML page for other regimens.

2 regimens on this page
2 variants on this page


IDH1 relapsed or refractory, salvage therapy

Ivosidenib monotherapy

back to top

Regimen

FDA-recommended dose
Study Evidence
DiNardo et al. 2018 (AG120-C-001) Phase I/II

Chemotherapy

Continued indefinitely

References

  1. 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 protocol PubMed

IDH2 Relapsed or refractory, salvage therapy

Enasidenib monotherapy

back to top

Regimen

FDA-recommended dose
Study Evidence Efficacy
Stein et al. 2017 (AG-221-C-001) Phase I/II ORR: 40%

This is the dose used in the phase II expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.

Chemotherapy

28-day cycles

References

  1. AG-221-C-001: 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 verified protocol link to PMC article PubMed