Quizartinib plus chemotherapy improves OS in patients with AML undergoing ASCT

In patients with newly diagnosed acute myeloid leukaemia (AML) with FLT3 internal tandem duplication (ITD), the addition of quizartinib on top of standard induction and consolidation therapy improved overall survival (OS) in the phase 3 QuANTUM-First trial. Findings from a subset of patients who underwent allogeneic stem cell transplantation (ASCT) in first complete remission showed that quizartinib still resulted in significant 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 maintenance therapy after standard high-dose cytarabine consolidation or ASCT in first complete remission,” explained Prof. Radovan Vrhovac (University Hospital Centre Zagreb, Croatia) [1,2]. 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 as maintenance, 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 0.78; 95% CI 0.62-0.98; P=0.032) [3]. Prof. Vrhovac presented the findings from a subset of patients who underwent ASCT in first complete remission.

In total, 157 participants underwent ASCT in first complete remission. Multivariate analysis in this subset of patients showed that treatment with quizartinib (HR 0.77; 95% CI 0.61–0.97; P=0.028), as well as ASCT in complete 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 were transplanted or not.

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) 49^th Annual Meeting, 23–26 April 2023, Paris, France.
2. Erba HP, et a;. Lancet. 2023;401(10388):1571–1583.
3. Erba HP, et al. Hemasphere. 2022;6(S3):S100.

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Posted on 14 June 202315 February 2024