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Gemtuzumab ozogamicin in first-line treatment of CBF-AML: insights from a retrospective multi-center analysis : acute myeloid leukemia

The addition of gemtuzumab ozogamicin (GO) to intensive chemotherapy (IC) has become a mainstay in treating patients with core binding factor acute myeloid leukemia (CBF-AML). However, evidence for the efficacy of GO in this particular subgroup is primarily based on meta-analytic data from different...

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Main Authors: Ronnacker, Julian (Author) , Muller, Philippe J. (Author) , Mikesch, Jan-Henrik (Author) , Zukunft, Sven (Author) , Weinbergerová, Barbora (Author) , Šrámek, Jiří (Author) , Valka, Jan (Author) , Novak, Jan (Author) , Zak, Pavel (Author) , Szotkowski, Tomas (Author) , Koristek, Zdenek (Author) , Krekeler, Carolin (Author) , Unglaub, Julia Marie (Author) , Sauer, Tim (Author) , Ruhnke, Leo (Author) , Kraus, Sabrina (Author) , Schaffrath, Judith (Author) , Müller, Lutz P. (Author) , Kaes, Sabrina (Author) , Niemann, Dirk (Author) , Fransecky, Lars (Author) , Hess, Patrick P. (Author) , Crysandt, Martina (Author) , Jost, Edgar (Author) , Millo, Joana (Author) , Gaertner, Johannes (Author) , Repp, Roland (Author) , Jentzsch, Madlen (Author) , Hoppe, Lea (Author) , Klein, Stefan (Author) , Modemann, Franziska (Author) , Michalowski, Nina (Author) , Fischbach, Klaudia (Author) , Blau, Wolfgang (Author) , Ruhs, Marion (Author) , Ritter, Markus (Author) , Lohmeyer, Julian (Author) , Steffen, Björn (Author) , Hauser, Sarah (Author) , Kaufmann, Martin (Author) , Krause, Stefan W. (Author) , Knabe, Ricarda (Author) , Spiekermann, Karsten (Author) , Serve, Hubert (Author) , Platzbecker, Uwe (Author) , Baldus, Claudia D. (Author) , Müller-Tidow, Carsten (Author) , Lenz, Georg (Author) , Reinhardt, Hans Christian (Author) , Mayer, Jirí (Author) , Bornhäuser, Martin (Author) , Röllig, Christoph (Author) , Schliemann, Christoph (Author) , Hanoun, Maher (Author)
Format: Article (Journal)
Language:English
Published: 21 July 2025
In: Leukemia
Year: 2025, Volume: 39, Issue: 9, Pages: 2174-2180
ISSN:1476-5551
DOI:10.1038/s41375-025-02700-9
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41375-025-02700-9
Verlag, kostenfrei, Volltext: http://www.nature.com/articles/s41375-025-02700-9
Resolving-System, kostenfrei: https://doi.org/10.25673/120891
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Author Notes:Julian Ronnacker, Philippe J. Muller, Jan-Henrik Mikesch, Sven Zukunft, Barbora Weinbergerová, Jiří Šrámek, Jan Valka, Jan Novak, Pavel Zak, Tomas Szotkowski, Zdenek Koristek, Carolin Krekeler, Julia M. Unglaub, Tim Sauer, Leo Ruhnke, Sabrina Kraus, Judith Schaffrath, Lutz P. Müller, Sabrina Kaes, Dirk Niemann, Lars Fransecky, Patrick P. Hess, Martina Crysandt, Edgar Jost, Joana Millo, Johannes Gaertner, Roland Repp, Madlen Jentzsch, Lea Hoppe, Stefan Klein, Franziska Modemann, Nina Michalowski, Klaudia Fischbach, Wolfgang Blau, Marion Ruhs, Markus Ritter, Julian Lohmeyer, Björn Steffen, Sarah Hauser, Martin Kaufmann, Stefan W. Krause, Ricarda Knabe, Karsten Spiekermann, Hubert Serve, Uwe Platzbecker, Claudia D. Baldus, Carsten Müller-Tidow, Georg Lenz, Hans Christian Reinhardt, Jirí Mayer, Martin Bornhäuser, Christoph Röllig, Christoph Schliemann and Maher Hanoun

MARC

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520 |a The addition of gemtuzumab ozogamicin (GO) to intensive chemotherapy (IC) has become a mainstay in treating patients with core binding factor acute myeloid leukemia (CBF-AML). However, evidence for the efficacy of GO in this particular subgroup is primarily based on meta-analytic data from different trials conducted more than a decade ago. In this registry-based study, we evaluated the impact of adding GO to IC in 265 CBF-AML patients from the SAL, AMLCG, and CELL cooperative study groups. Patients receiving GO had a 2-year overall survival of 90% compared with 80% in those without GO (hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.21-0.95, P = 0.036) and a 2-year event-free survival of 51% versus 36% (HR 0.69, 95% CI 0.48-0.99, P = 0.046). While complete remission rates in GO vs. non-GO patients were comparable (89% vs. 90%, P = 0.81), more GO patients achieved measurable residual disease-negative remission (77% vs. 49%, P < 0.001), resulting in numerically reduced cumulative incidence of relapse (HR 0.67, 95% CI 0.43-1.02, P = 0.06). Despite delayed platelet recovery, high-grade toxicities were not increased in GO-treated patients. These findings support the integration of GO into treatment protocols for IC-eligible patients with CBF-AML. 
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