Difference between revisions of "Staging page"

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[[#top|Back to Top]]
 
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{{#lst:Section editor transclusions|aml}}
 
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<big>'''Note: these are regimens tested in biomarker-specific populations for patients with IDH-mutated AML, please see the [[Acute myeloid leukemia|main AML page]] for other regimens.'''</big>
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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|}
 
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{{TOC limit|limit=3}}
 
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=IDH1 first-line therapy, older or 'unfit' patients=
 
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==Azacitidine monotherapy {{#subobject:791718|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen {{#subobject:7509ab|Variant=1}}===
 
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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! style="width: 20%" |Study
 
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! style="width: 20%" |Years of enrollment
 
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! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
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! style="width: 20%" |Comparator
 
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! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|-
 
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|[https://doi.org/10.1056/nejmoa2117344 Montesinos et al. 2022 (AGILE)]
 
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|2018-2021
 
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| style="background-color:#1a9851" |Phase 3 (C)
 
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|[[#Azacitidine_.26_Ivosidenib|Azacitidine & Ivosidenib]]
 
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| style="background-color:#d73027" |Inferior OS
 
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|-
 
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|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*IDH1 mutation
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Chemotherapy====
 
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*[[Azacitidine (Vidaza)]] 75 mg/m<sup>2</sup> IV or SC once per day on days 1 to 7
 
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'''28-day cycles'''
 
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</div></div>
 
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===References===
 
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#'''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. [https://doi.org/10.1056/nejmoa2117344 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35443108/ PubMed] NCT03173248
 
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==Azacitidine & Ivosidenib {{#subobject:79gjaa8|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen {{#subobject:7y15ab|Variant=1}}===
 
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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! style="width: 20%" |Study
 
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! style="width: 20%" |Years of enrollment
 
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! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
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! style="width: 20%" |Comparator
 
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! style="width: 20%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|-
 
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|[https://doi.org/10.1056/nejmoa2117344 Montesinos et al. 2022 (AGILE)]
 
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|2018-2021
 
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
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|[[#Azacitidine_monotherapy|Azacitidine]]
 
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| style="background-color:#1a9850" |Superior OS<br>Median OS: 24 vs 7.9 mo<br>(HR 0.44, 95% CI 0.27-0.73)
 
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|-
 
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|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*IDH1 mutation
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Chemotherapy====
 
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*[[Azacitidine (Vidaza)]] 75 mg/m<sup>2</sup> IV or SC once per day on days 1 to 7
 
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====Targeted therapy====
 
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*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day
 
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'''28-day cycles'''
 
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</div></div>
 
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===References===
 
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#'''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. [https://doi.org/10.1056/nejmoa2117344 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/35443108/ PubMed] NCT03173248
 
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==Ivosidenib monotherapy {{#subobject:b11758|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen {{#subobject:40a68c|Variant=1}}===
 
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{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
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|-
 
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|}
 
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{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
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!style="width: 33%"|Study
 
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!style="width: 33%"|Years of enrollment
 
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|-
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7019193/ Roboz et al. 2019 (AG120-C-001)]
 
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|2014-2017
 
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| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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|-
 
−
|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*Gene: IDH1
 
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*Alteration: R132
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Targeted therapy====
 
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*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day
 
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'''Continued indefinitely'''
 
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</div></div>
 
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===References===
 
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#'''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. [https://doi.org/10.1182/blood.2019002140 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7019193/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31841594/ PubMed] NCT02074839
 
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#'''HOVON 150 AML:''' NCT03839771
 
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=IDH1 relapsed or refractory, salvage therapy=
 
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==Ivosidenib monotherapy {{#subobject:214f83|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen {{#subobject:e548f6|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
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|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 
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!style="width: 25%"|Study
 
−
!style="width: 25%"|Years of enrollment
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
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|[https://doi.org/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001)]
 
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|2014-2017
 
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| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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| style="background-color:#8c96c6" |ORR: 42%
 
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|-
 
−
|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*Alteration: IDH1 R132 gene variant
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Targeted therapy====
 
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*[[Ivosidenib (Tibsovo)]] 500 mg PO once per day
 
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'''Continued indefinitely'''
 
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</div></div>
 
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===References===
 
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#'''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://doi.org/10.1056/NEJMoa1716984 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29860938 PubMed] NCT02074839
 
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==Olutasidenib monotherapy {{#subobject:21gj23|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:e5kgx6|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|Years of enrollment
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
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|-
 
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|[https://doi.org/10.1016/s2352-3026(22)00292-7 Watts et al. 2022 (2102-HEM-101)]
 
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|2016-2018
 
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| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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| style="background-color:#8c96c6" |CR+CRh rate: 35%
 
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|-
 
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|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*Alteration: IDH1 R132 gene variant
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Targeted therapy====
 
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*[[Olutasidenib (Rezlidhia)]] 150 mg PO twice per day
 
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'''Continued indefinitely'''
 
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</div></div>
 
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===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. [https://doi.org/10.1016/s2352-3026(22)00292-7 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36370742/ PubMed] NCT02719574
 
−
=IDH2 first-line therapy, older or 'unfit' patients=
 
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==Enasidenib monotherapy {{#subobject:b11758|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:40a68c|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
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!style="width: 33%"|Study
 
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!style="width: 33%"|Years of enrollment
 
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|-
 
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|[https://doi.org/10.1038/s41375-019-0472-2 Pollyea et al. 2019 (AG-221-C-001 untreated)]
 
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|2013-NR
 
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| style="background-color:#91cf61" |Phase 1/2
 
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|-
 
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|}
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*Alteration: IDH2 gene variant
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Targeted therapy====
 
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*[[Enasidenib (Idhifa)]] 100 mg PO once per day
 
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'''28-day cycles'''
 
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</div></div>
 
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===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. [https://doi.org/10.1038/s41375-019-0472-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30967620 Pubmed] NCT01915498
 
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=IDH2 Relapsed or refractory, salvage therapy=
 
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==Enasidenib monotherapy {{#subobject:226cb2|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen {{#subobject:c110c9|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
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|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 80%; text-align:center;"
 
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!style="width: 25%"|Study
 
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!style="width: 25%"|Years of enrollment
 
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ Stein et al. 2017 (AG-221-C-001 relapsed)]
 
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|2013-2016
 
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| style="background-color:#91cf61" |Phase 1/2 (RT)
 
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| style="background-color:#8c96c6" |ORR: 40%
 
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|-
 
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|}
 
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''This is the dose used in the phase 2 expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.''
 
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<div class="toccolours" style="background-color:#fdcdac">
 
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====Biomarker eligibility criteria====
 
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*Alteration: IDH2 gene variant
 
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</div>
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Targeted therapy====
 
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*[[Enasidenib (Idhifa)]] 100 mg PO once per day
 
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'''28-day cycles'''
 
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</div></div>
 
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===References===
 
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#'''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. [http://www.bloodjournal.org/content/130/6/722.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5572791/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28588020 PubMed] NCT01915498
 
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[[Category:Acute myeloid leukemia regimens]]
 
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[[Category:Biomarker-specific pages]]
 
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[[Category:Acute leukemias]]
 

Latest revision as of 00:13, 18 June 2023

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