VIALE-A was a randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy and safety of VEN+AZA vs placebo (PBO)+AZA in newly diagnosed patients with AML who were ≥75 years of age, or had comorbidities that precluded the use of intensive induction chemotherapy.
Complete remission (CR) was defined as absolute neutrophil count (ANC) >1,000/microliter, platelets >100,000/microliter, RBC transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.
Complete remission with partial hematologic recovery (CRh) was defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).
AML=acute myeloid leukemia; CLcr=creatinine clearance; ECOG=Eastern Cooperative Oncology Group; IV=intravenous; RBC=red blood cell; TLS=tumor lysis syndrome.
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VENCLEXTA Prescribing Information.
VENCLEXTA Prescribing Information.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 17, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 17, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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Data on file, AbbVie Inc. ABVRRTI71211.
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Data on file, AbbVie Inc. ABVRRTI71272.
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Data on file, AbbVie Inc. ABVRRTI67697.
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CRESEMBA Prescribing Information.
CRESEMBA Prescribing Information.
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Data on file, Genentech, Inc. 07/2022.
Data on file, Genentech, Inc. 07/2022.
Data on file, AbbVie Inc. ABVRRTI73540.
Data on file, AbbVie Inc. ABVRRTI73540.
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Data on file, AbbVie Inc. ABVRRTI74719.
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Pratz KW, Jonas BA, Pullarkat V, et al. Long-term follow-up of the phase 3 VIALE-A clinical trial of venetoclax plus azacitidine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy. Oral abstract presented at: 64th ASH Annual Meeting and Exposition; December 10, 2022; New Orleans, Louisiana. https://clin.larvol.com/abstract-detail/ASH%202022/61249960
Pratz KW, Jonas BA, Pullarkat V, et al. Long-term follow-up of the phase 3 VIALE-A clinical trial of venetoclax plus azacitidine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy. Oral abstract presented at: 64th ASH Annual Meeting and Exposition; December 10, 2022; New Orleans, Louisiana. https://clin.larvol.com/abstract-detail/ASH%202022/61249960
The survey was not designed to measure preferences for venetoclax fixed-duration regimens.
When 608 patients and 22 caregivers were asked about preference for duration of CLL therapy, if effectiveness and side effects were assumed similar:
Survey question results:
Limitations include the opt-in sample where the survey results may not be reflective of the general CLL population and their caregivers.
*Until disease progression or intolerance.
uMRD=undetectable minimal residual disease.
References
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31. Koffman B, Stewart C, Avruch L, et al. Awareness, knowledge, and preferences of United States (US) patient with chronic lymphocytic leukemia (CLL) and their caregivers related to finite duration (FD) therapy and minimal (measurable) residual disease (MRD). Poster presented at: 63rd ASH Annual Meeting and Exposition; December 11-14, 2021.
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