Prognostic impact of measurable residual disease in AML patients treated frontline with azacitidine and venetoclax: results from the French VENAURA registry

Measurable residual disease (MRD) is a key prognostic marker in acute myeloid leukemia (AML), but its significance in patients treated with azacitidine and venetoclax (AZA/VEN) outside clinical trials remains unclear. We retrospectively analyzed 220 newly diagnosed AML patients from the French VENAURA registry who achieved composite complete remission and underwent MRD evaluation by multiparametric flow cytometry (MFC, LAIP/LSC) and/or NPM1 RT-qPCR. Cumulative MRD negativity was achieved in 62-67% of patients. Attaining MRD negativity at any time was strongly associated with superior overall survival (OS: 31.3 months vs 15.7 months (HR = 0.47) for LAIP, not reached vs 10.8 months (HR = 0.38) for NPM1; all p < 0.001) and lower cumulative incidence of relapse. Dual LAIP/LSC negativity (NEG/NEG) conferred the best outcomes compared to NEG/POS (HR = 0.36, p = 0.02), POS/NEG (HR = 0.24, p < 0.001) and POS/POS (HR = 0.26, p = 0.26) status. Importantly, MRD response mitigated the adverse prognostic impact of ELN 2024 intermediate/poor risk, with MRD-negative patients achieving outcomes comparable to favorable-risk cases. MRD kinetics (early vs late responders) did not affect survival, while G-CSF use improved MRD conversion and OS. In real-world AZA/VEN-treated AML, achieving deep MRD negativity, by MFC or NPM1 RT-qPCR, emerges as the dominant prognostic determinant, overriding baseline risk and supporting its integration into response-adapted strategies.

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Journal
Leukemia
Published
2026-07-17
DOI
https://doi.org/10.1038/s41375-026-03024-y
Primary Topic
Acute Myeloid Leukemia Research
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article
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article

Prognostic impact of measurable residual disease in AML patients treated frontline with azacitidine and venetoclax: results from the French VENAURA registry

Emmanuel Beillard, Delphine Manzoni, Maël Heiblig, Emmanuelle Tavernier et al.
Leukemia
Acute Myeloid Leukemia Research
article

Prognostic impact of measurable residual disease in AML patients treated frontline with azacitidine and venetoclax: results from the French VENAURA registry

Emmanuel Beillard, Delphine Manzoni, Maël Heiblig, Emmanuelle Tavernier, Ugo Thévenet, Lucie Coster, Adriana Pleșa, Nadine Boullanger, Natacha Mauz, Urbain Tauveron-Jalenques, Sylvain Lamure, Amine Belhabri, Adrien Contejean, Jérôme Cornillon, Samy Chraïbi, Clément Rocher, Gian Matteo Pica, Grégoire Le Meur, Thomas Tassin, Mathieu Meunier, Clémence Santana, Gaspar Aspa Requena, Serge Carillo, Sarah Huet, Martin Carré, Pascale Flandrin‐Gresta, Mauricette Michallet, Zofia Gross, Sylvie Tondeur, Arthur Dony
article en

Abstract

Measurable residual disease (MRD) is a key prognostic marker in acute myeloid leukemia (AML), but its significance in patients treated with azacitidine and venetoclax (AZA/VEN) outside clinical trials remains unclear. We retrospectively analyzed 220 newly diagnosed AML patients from the French VENAURA registry who achieved composite complete remission and underwent MRD evaluation by multiparametric flow cytometry (MFC, LAIP/LSC) and/or NPM1 RT-qPCR. Cumulative MRD negativity was achieved in 62-67% of patients. Attaining MRD negativity at any time was strongly associated with superior overall survival (OS: 31.3 months vs 15.7 months (HR = 0.47) for LAIP, not reached vs 10.8 months (HR = 0.38) for NPM1; all p < 0.001) and lower cumulative incidence of relapse. Dual LAIP/LSC negativity (NEG/NEG) conferred the best outcomes compared to NEG/POS (HR = 0.36, p = 0.02), POS/NEG (HR = 0.24, p < 0.001) and POS/POS (HR = 0.26, p = 0.26) status. Importantly, MRD response mitigated the adverse prognostic impact of ELN 2024 intermediate/poor risk, with MRD-negative patients achieving outcomes comparable to favorable-risk cases. MRD kinetics (early vs late responders) did not affect survival, while G-CSF use improved MRD conversion and OS. In real-world AZA/VEN-treated AML, achieving deep MRD negativity, by MFC or NPM1 RT-qPCR, emerges as the dominant prognostic determinant, overriding baseline risk and supporting its integration into response-adapted strategies.

Leukemia
Université Claude Bernard Lyon 1 (FR), Centre National de la Recherche Scientifique (FR), Inserm (FR), Centre Hospitalier Universitaire de Grenoble (FR), Institut Gustave Roussy (FR), Centre Hospitalier Universitaire de Montpellier (FR), Centre de Recherche en Neurosciences de Lyon (FR), Hospices Civils de Lyon (FR), Hôpital Jeanne de Flandre (FR), Centre Hospitalier Universitaire de Nîmes (FR), Centre Léon Bérard (FR), Centre Hospitalier Métropole Savoie (FR), Institut de Cancérologie de Bourgogne (FR), Hôpital Lyon Sud (FR), Hôpital Nord (FR), Hôpitaux Universitaires Paris-Ouest (FR), Int'Air Medical (France) (FR), Cythelia (France) (FR), Centre de Recherche en Cancérologie de Lyon (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Centre Hospitalier Annecy Genevois (FR), Centre Hospitalier de Valence (FR), Hôpital Saint-Jacques (FR), Institut Agama Islam Negeri Manado (ID), Agir Pour les Maladies Chroniques (FR), Centre Hospitalier Universitaire de Saint-Étienne (FR), Centre International de Recherche en Infectiologie (FR), Cytoskeleton (United States) (US), Université Paris Dauphine-PSL (FR), Université de Nîmes (FR)
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