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2024-07-29T08:53:53.000Z

QuANTUM-First: Efficacy analysis in newly diagnosed FLT3-ITD-positive AML

Jul 29, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in AML.


An exploratory analysis from QuANTUM-First (NCT02668653), a phase III study of quizartinib plus chemotherapy in patients with newly diagnosed FLT3-internal tandem duplication (ITD)-positive acute myeloid leukemia (AML) who received continuation therapy, was presented at the European Hematology Association 2024 Hybrid Congress by Mikkael Sekeres.1


Key learnings1
At a median follow-up of 39.2 months, median overall survival (OS) was not reached in either the quizartinib (n = 116) or placebo arms (n = 92) (hazard ratio [HR], 0.683; 95% confidence interval [CI], 0.395–1.183). However, at 48 months the OS rate was numerically higher for quizartinib (76.3%) vs placebo (67.9%). 
From baseline to 36 months, a higher relapse-free survival (RFS) rate was observed in the quizartinib arm. However, in the long-term, median RFS was not reached in the placebo arm and was 48.6 months with quizartinib. 
A higher proportion of patients (71%) in the quizartinib arm proceeded to continuation therapy after allogenic-hematopoietic stem cell transplant (allo-HSCT) vs placebo (55%).
In patients who did not receive allo-HSCT, there was an OS benefit in those treated with quizartinib, with a 60% reduction in the risk of death compared with placebo.
These findings support the use of quizartinib throughout the treatment regimen in patients with ND FLT3-mutated AML and suggest that implementation of measurable residual disease in future studies may help identify patients who will receive the most benefit from treatment with quizartinib.

  1. Sekeres M. QuANTUM-First: Efficacy in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication–positive (FLT3-ITD+) acute myeloid leukemia (AML) who received continuation therapy. Oral abstract #S142. Presented at: European Hematology Association 2024 Hybrid Congress. Jun 13–16, 2024; Madrid, ES .

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