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Survival outcomes in newly diagnosed acute myeloid leukemia patients treated with venetoclax and a hypomethylating agent are comparable across 7-, 14-, 21-, and 28-day venetoclax cycles, with overall survival primarily driven by baseline genetic risk. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This research investigates the optimal duration of venetoclax combined with hypomethylating agents in newly diagnosed acute myeloid leukemia patients based on genetic risk profiles.

May 29, 2026Journal of Clinical Oncology0 citations

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HMA plus venetoclax for 7- vs 14- vs 21- vs 28-day cycles in newly-diagnosed acute myeloid leukemia: ELN- and Mayo Genetic Risk–stratified analysis in 540 patients.

SKSudhesh Kumar MWMomna Warraich MFMahnoor Fatima

Key Points

This research investigates the optimal duration of venetoclax combined with hypomethylating agents in newly diagnosed acute myeloid leukemia patients based on genetic risk profiles.
Retrospective analysis of 540 newly diagnosed acute myeloid leukemia patients treated with venetoclax and hypomethylating agents at the Mayo Clinic.
Patients categorized using ELN and Mayo Genetic risk models to evaluate treatment responses across varying venetoclax durations (7, 14, 21, 28 days).
Statistical analyses performed to compare outcomes including complete response rates, survival outcomes, and early mortality.
Median overall survival was similar across treatment durations (13-17 months) with p=0.84, highlighting comparable efficacy.
30-day mortality rates were significantly higher with 7- and 14-day treatments compared to 28-day (p=0.07/p=0.03).
CR rates varied although not significantly across durations, with 7-day treatment showing lower response rates compared to 21-day (p=0.04).

Abstract

6525 Background: Venetoclax plus hypomethylating agent (Ven-HMA) is the standard treatment for unfit patients with newly diagnosed acute myeloid leukemia (ND-AML), with Ven typically administered for 28 days (d) per cycle (DiNardo NEJM 2020) . However, the optimal duration of Ven across risk groups remains unclear. We examined survival outcomes with Ven 7, 14, 21, and 28d in ND-AML, in the context of European LeukemiaNet (ELN) and Mayo Genetic risk models. Methods: ND-AML patients receiving Ven-HMA at the Mayo Clinic were retrospectively studied. Patients were stratified by ELN 2024 (Döhner Blood 2024) and Mayo Genetic risk (Gangat Am J Hematol 2025) , and analyzed using standard statistical methods. Results: 540 patients (median age 75 years, 52% de novo) received HMA with Ven for 7d ( n =33), 14d ( n =117), 21d ( n =96), or 28d ( n =294). ELN and Mayo risk distributions were 22%/35% high, 18%/56% intermediate, 60%/9% low risk, respectively. Baseline characteristics were comparable. CR/CRi rates were comparable across Ven durations, with the exception of lower CR/CRi with 7d vs 21d (p=0.04). Risk-stratified CR/CRi showed variations across Mayo and ELN groups but without significant differences based on Ven duration (Table). Allogeneic transplant rates were 15%, 18%, 18%, 20% for 7, 14, 21, 28d (p=0.86). At a median followup of 37.7 months, median overall survival (OS) differed by ELN risk (6.6, 11.9, 20 months) and Mayo genetic risk (7.8, 17.4 months, not reached (NR)), for high, intermediate, low risk (p0.1). Conclusions: Survival outcomes were comparable across Ven 7, 14, 21, 28 d in ND-AML, with outcomes driven by Mayo Genetic and ELN risk. Despite differences by Ven duration in high-risk groups, higher early mortality with 7d and 14d likely reflects treatment selection. Prospective trials are needed to establish risk adapted Ven dosing strategies. 7 (N=33) 14 (N=117) 21 (N=96) 28 (N=294) P-value CR/CRi (%) 52 63 72 65 0.19 7≠21 Mayo Risk High 33 49 58 55 0.53 - Intermediate 55 69 80 69 0.17 7≠21 Low 100 85 80 84 0.84 - ELN Risk High 33 30 57 53 0.21 - Intermediate 33 59 64 56 0.63 - Low 62 74 80 73

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HMA plus venetoclax for 7- vs 14- vs 21- vs 28-day cycles in newly-diagnosed acute myeloid leukemia: ELN- and Mayo Genetic Risk–stratified analysis in 540 patients.

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