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Quizartinib provides benefits on top of ASCT in AML

Presented By
Prof. Radovan Vrhovac, University Hospital Zagreb, Croatia
EBMT 2023
Phase 3, QuANTUM-First

In patients with newly diagnosed acute myeloid leukaemia (AML) with FLT3 internal tandem duplication (ITD), additional quizartinib, on top of standard induction and consolidation therapy, improved overall survival in the phase 3 QuANTUM-First trial. Moreover, in the subset of patients who underwent allogeneic stem cell transplantation (ASCT) in first clinical remission, quizartinib still resulted in significant overall survival (OS) improvement.

“The QuANTUM-First study (NCT02668653) is the first randomised trial examining the efficacy and safety of a specific FLT3 inhibitor in patients with AML and FLT3-ITD receiving up to 3 years of continuation therapy after standard high-dose cytarabine consolidation or ASCT in first clinical remission,” explained Prof. Radovan Vrhovac (University Hospital Zagreb, Croatia) [1]. In the QuANTUM-First trial, participants with newly diagnosed FLT3-ITD AML between 18 and 75 years of age (n=539) were randomised 1:1 to additional quizartinib during induction, consolidation, and continuation, or to placebo. After a median follow-up of 39 months, the primary endpoint of OS was met (median OS 31.9 months vs 15.1 months; HR 0.776; P=0.032) [2]. Prof. Vrhovac presented additional findings from the subset of patients who underwent ASCT in first clinical remission.

In total, 157 patients underwent ASCT in first clinical remission. A multivariate analysis in this subset of patients showed that both treatments with quizartinib (HR 0.77; 95% CI 0.61–0.97; P=0.028), as well as ASCT in first clinical remission (HR 0.42; 95% CI 0.30–0.60; P<0.0001) had a positive and significant impact on OS. Prof. Vrhovac commented that these results were significant irrespective of pre-ASCT MRD status.

In conclusion, quizartinib provided a clinically meaningful improvement in OS compared with standard induction and consolidation therapy alone in patients with newly diagnosed AML with FLT3-ITD, irrespective of whether patients underwent ASCT in first clinical remission.

    1. Schlenck RF, et al. Impact of allogeneic hematopoietic cell transplantation in first complete remission in addition to FLT3 inhibition with quizartinib in acute myeloid leukemia with FLT3-internal tandem duplication: Results from the QuANTUM-First Trial. OS01-04, European Society for Blood and Marrow Transplantation (EBMT) 49th Annual Meeting, 23–26 April 2023, Paris, France.
    2. Erba H, et al. Hemasphere. 2022;6(S3):S100.


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