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IC in combination with quizartinib or midostaurin for ND FLT3-ITD AML: A multicenter cohort study
Results from a multicenter, retrospective cohort study evaluating intensive chemotherapy (IC; daunorubicin or idarubicin + cytarabine) in combination with quizartinib (n = 88) or midostaurin (n = 127) in patients with newly diagnosed (ND) FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukemia (AML) were presented by Michelle Lee at the European Hematology Association (EHA) 2026 Congress, June 11–14, 2026, Stockholm, SE. The primary endpoint was 1-year overall survival (OS).
Key data: At a median follow-up of 464 days, the 1-year OS rate was 93% (95% confidence interval [CI], 85–97) with quizartinib vs 78% (95% CI, 69–84) with midostaurin (hazard ratio [HR], 0.19; p = 0.013); and 1-year event-free survival (EFS) rates were 77% (95% CI, 65–86) vs 56% (95% CI, 46–64; HR, 0.44; p = 0.011), respectively. Overall, 85.2% of patients receiving quizartinib vs 73.2% of patients receiving midostaurin achieved a composite complete response (cCR) after induction (odds ratio [OR], 2.19; p < 0.05). Post-induction minimal residual disease (MRD) negativity rates with quizartinib vs midostaurin were 40.3% vs 38.5% (p = 0.84), and 70.4% vs 65.0% (p = 0.70) of patients with MRD-negativity proceeded to hematopoietic stem cell transplantation (HSCT) in first complete remission (CR1). Rates of tyrosine kinase inhibitor (TKI) delays/interruptions (p = 0.01) and intensive care unit (ICU) utilization (p = 0.02) were lower with quizartinib vs midostaurin.
Key learning: At 1 year, quizartinib + IC was associated with improved outcomes vs midostaurin + IC, in real-world patients with ND FLT3-ITD AML.
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