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Comment
. 2021 Sep 1;39(25):2742-2748.
doi: 10.1200/JCO.21.00080. Epub 2021 Jun 4.

Harnessing the Therapeutic Value of Venetoclax: A Breakthrough Therapy in Acute Myeloid Leukemia

Andrew H Wei  1 , Gail J Roboz  2 , Hagop M Kantarjian  3
Affiliations
Comment

Harnessing the Therapeutic Value of Venetoclax: A Breakthrough Therapy in Acute Myeloid Leukemia

Andrew H Wei et al. J Clin Oncol. .
No abstract available

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Conflict of interest statement

Andrew H. WeiHonoraria: Amgen, Servier, Novartis, Celgene, AbbVie/Genentech, Pfizer, Janssen Oncology, Astellas Pharma, Macrogenics, AstraZenecaConsulting or Advisory Role: Servier, Novartis, Amgen, AbbVie/Genentech, Celgene, Macrogenics, Pfizer, Astellas Pharma, AstraZeneca, JanssenSpeakers' Bureau: AbbVie/Genentech, Novartis, Celgene/Bristol Myers SquibbResearch Funding: Novartis, Celgene, AbbVie, AstraZeneca, Servier, Amgen, RochePatents, Royalties, Other Intellectual Property: A.H.W. is a former employee of the Walter and Eliza Hall Institute which receives milestone and royalty payments related to venetoclax, and is eligible for benefits related to these payments. A.H.W. receives payments from WEHI related to venetoclax Gail J. RobozConsulting or Advisory Role: Amphivena, Janssen, Amgen, Astex Pharmaceuticals, Celgene, Genoptix, MedImmune, Novartis, Pfizer, AbbVie, argenx, Array BioPharma, Bayer, Celltrion, Jazz Pharmaceuticals, Orsenix, Genentech/Roche, Sandoz, Actinium Pharmaceuticals, Astellas Pharma, Eisai, Bayer, Daiichi Sankyo, MEI Pharma, Otsuka, Takeda, Roche, Agios, Trovagene, GlaxoSmithKline, Bristol Myers Squibb, Helsinn Therapeutics, MesoblastResearch Funding: AbbVie, Agios, Astex Pharmaceuticals, Celgene, CTI, Karyopharm Therapeutics, MedImmune, MEI Pharma, Moffitt, Novartis, Onconova Therapeutics, Pfizer, Sunesis Pharmaceuticals, Tensha Therapeutics, Cellectis, Janssen, AmphivenaTravel, Accommodations, Expenses: Amphivena, Astex Pharmaceuticals, Janssen, Pfizer, Array BioPharma, Novartis, AbbVie, Jazz Pharmaceuticals, Celgene, Celltrion, Roche/Genentech, Sandoz, Bayer, Clovis Oncology, Amgen, Sunesis Pharmaceuticals, Eisai, Agios Hagop M. KantarjianHonoraria: AbbVie, Amgen, ARIAD, Bristol Myers Squibb, Immunogen, Orsenix, Pfizer, Agios, Takeda, Actinium PharmaceuticalsResearch Funding: Pfizer, Amgen, Bristol Myers Squibb, Novartis, ARIAD, Astex Pharmaceuticals, AbbVie, Agios, Cyclacel, Immunogen, Jazz PharmaceuticalsNo other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Randomized survival outcomes for approved therapies in acute myeloid leukemia including midostaurin, CPX-351, glasdegib, ENA, GO, gilteritinib, oral AZA (CC-486), and VEN. Comparison of the survival curves from the VIALE-C study showing the primary analysis: (A) 7 + 3 + midostaurin, (B) CPX-351, (C) 7 + 3 + GO, (D) gilteritinib, (E) LDAC + glasdegib, (F) AZA + ENA, (G) CC-486, and (H) AZA + VEN. AZA, azacitidine; ENA, enasidenib; GO, gemtuzumab ozogamicin; HR, hazard ratio; LDAC, low-dose cytarabine; VEN, venetoclax. (A) From The New England Journal of Medicine, Stone RM, Mandrekar SJ, Sanford BL, et al, Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation, 377:454-464, Copyright © 2017, Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. (B) From Lancet JE, Uy GL, Cortes JE, et al, CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol, 36:2684-2692, 2018. (C) Reprinted from The Lancet, 379, Castaigne S, Pautas C, Terre' C, et al, Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): A randomised, open-label, phase 3 study, 1508-1516, 2012, with permission from Elsevier. (D) From The New England Journal of Medicine, Perl AE, Martinelli G, Cortes JE, et al, Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML, Copyright © 2019, Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. (E) Republished with permission of Elsevier Science & Technology Journals, from Venetoclax plus LDAC for patients with untreated AML ineligible for intensive chemotherapy: Phase 3 randomized placebo-controlled trial, Wei AH, Montesinos P, Ivanov V, et al, 135, 2137-2145, 2020; permission conveyed through Copyright Clearance Center, Inc. (G) From The New England Journal of Medicine, Wei AH, Döhner H, Pocock C, et al, Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission, 383:2526-2537, Copyright © 2020, Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society. (H) From The New England Journal of Medicine, DiNardo C, Jonas B, Pullarkat V, et al, Azacitidine and venetoclax in previously untreated acute myeloid leukemia, 383:617-629, Copyright © 2020, Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
FIG 2.
FIG 2.
(A) OS from the primary analysis with 12 months follow-up; (B) OS with 18 months median follow-up (additional 6 months in a post hoc analysis). In the primary analysis, a cluster of patients was censored between 3 and 6 months before the median OS timepoint was reached, compared to most censored events between 9 and 12 months in the updated analysis. In both analyses, there are few recorded observations at 24 months. LDAC, low-dose cytarabine; OS, overall survival; PBO, placebo; VEN, venetoclax.
FIG 3.
FIG 3.
Comparison of responses in the VIALE-A and VIALE-C studies. Numbers above bars represent % CR/CRi. AZA, azacitidine; CR, complete remission; CRi, CR with incomplete hematologic recovery; HMA, hypomethylating agent; LDAC, low-dose cytarabine; PBO, placebo; VEN, venetoclax.
See this image and copyright information in PMC

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References

    1. Wei AH, Montesinos P, Ivanov V, et al. : Venetoclax plus LDAC for patients with untreated AML ineligible for intensive chemotherapy: Phase 3 randomized placebo-controlled trial. Blood 135:2137-2145, 2020 - PMC - PubMed
    1. DiNardo C, Jonas B, Pullarkat V, et al. : Azacitidine and venetoclax in previously untreated acute myeloid leukemia. N Engl J Med 383:617-629, 2020 - PubMed
    1. DiNardo CD, Pratz K, Pullarkat V, et al. : Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood 133:7-17, 2019 - PMC - PubMed
    1. Wei AH, Strickland SA Jr, Hou J-Z, et al. : Venetoclax combined with low-dose cytarabine for previously untreated patients with acute myeloid leukemia: Results from a phase Ib/II study. J Clin Oncol 37:1277-1284, 2019 - PMC - PubMed
    1. Wei A, Strickland SA, Roboz GJ, et al. : Safety and efficacy of venetoclax plus low-dose cytarabine in treatment-naive patients aged ≥ 65 years with acute myeloid leukemia. Blood 128:102, 2016

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