Difference between revisions of "Acute myeloid leukemia, IDH-mutated"
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{| class="wikitable" style="width: 50%; text-align:center;" | {| class="wikitable" style="width: 50%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
|- | |- | ||
|[http://www.bloodjournal.org/content/132/Suppl_1/561 AG120-C-001] | |[http://www.bloodjournal.org/content/132/Suppl_1/561 AG120-C-001] | ||
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====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
| − | * Alteration: IDH1 R132 variant | + | |
| + | *Alteration: IDH1 R132 gene variant | ||
* | * | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | *[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | ||
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===References=== | ===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. 2019 Dec 16. Epub ahead of print [https://ashpublications.org/blood/article-lookup/doi/10.1182/blood.2019002140] [https://clinicaltrials.gov/ct2/show/NCT02074839 NCT02074839] | + | |
| + | #'''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. 2019 Dec 16. Epub ahead of print [https://ashpublications.org/blood/article-lookup/doi/10.1182/blood.2019002140] [https://clinicaltrials.gov/ct2/show/NCT02074839 NCT02074839] | ||
=IDH1 relapsed or refractory, salvage therapy= | =IDH1 relapsed or refractory, salvage therapy= | ||
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|} | |} | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://www.nejm.org/doi/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001)] | |[https://www.nejm.org/doi/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001)] | ||
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|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | *[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | ||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
===References=== | ===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. [https://www.nejm.org/doi/10.1056/NEJMoa1716984 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29860938 PubMed] | + | |
| + | #'''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. [https://www.nejm.org/doi/10.1056/NEJMoa1716984 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29860938 PubMed] | ||
=IDH2 Relapsed or refractory, salvage therapy= | =IDH2 Relapsed or refractory, salvage therapy= | ||
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|} | |} | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ Stein et al. 2017 (AG-221-C-001)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ Stein et al. 2017 (AG-221-C-001)] | ||
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''This is the dose used in the phase II expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.'' | ''This is the dose used in the phase II expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Enasidenib (Idhifa)]] 100 mg PO once per day | *[[Enasidenib (Idhifa)]] 100 mg PO once per day | ||
| Line 100: | Line 106: | ||
===References=== | ===References=== | ||
| − | # '''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. [http://www.bloodjournal.org/content/130/6/722.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/28588020 PubMed] | + | |
| + | #'''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. [http://www.bloodjournal.org/content/130/6/722.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/28588020 PubMed] | ||
[[Category:Acute myeloid leukemia regimens]] | [[Category:Acute myeloid leukemia regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Acute leukemias]] | [[Category:Acute leukemias]] | ||
Revision as of 23:22, 8 January 2020
| Section editor | |
|---|---|
 |
Martin W. Schoen, MD, MPH Saint Louis University St. Louis, MO  mwschoen
|
Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated AML, please see the main AML page for other regimens.
8 regimens on this page
8 variants on this page
|
IDH1 first-line therapy, older or 'unfit' patients
Ivosidenib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence |
|---|---|
| AG120-C-001 | Phase I/II |
Biomarker eligibility criteria
- Alteration: IDH1 R132 gene variant
Chemotherapy
- Ivosidenib (Tibsovo) 500 mg PO once per day
Continued indefinitely
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. 2019 Dec 16. Epub ahead of print [1] NCT02074839
IDH1 relapsed or refractory, salvage therapy
Ivosidenib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence | Efficacy |
|---|---|---|
| DiNardo et al. 2018 (AG120-C-001) | Phase I/II (RT) | ORR: 42% |
Chemotherapy
- Ivosidenib (Tibsovo) 500 mg PO once per day
Continued indefinitely
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 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 (RT) | 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
- Enasidenib (Idhifa) 100 mg PO once per day
28-day cycles
References
- 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