Adding quizartinib to standard chemotherapy appears to improve overall survival (OS) among patients with newly diagnosed FLT3-internal tandem duplication (ITD)-positive acute myeloid leukemia (AML), according to research published in The Lancet. The improved outcomes were noted regardless of whether patients underwent allogeneic hematopoietic cell transplantation (allo-HCT).

Quizartinib is an orally administered selective inhibitor of type 2 FLT3. In previous studies, quizartinib with chemotherapy showed anticancer activity among patients with FLT3-ITD-positive disease. For the randomized phase 3 QuANTUM-First study ( Identifier: NCT02668653), researchers evaluated the safety and efficacy of adding quizartinib to chemotherapy — in comparison with placebo plus chemotherapy — among patients with newly diagnosed, FLT3-ITD-positive AML.

Overall, 539 patients were randomly assigned to receive quizartinib plus chemotherapy (268 patients) or placebo plus chemotherapy (271 patients). At baseline, in the quizartinib and chemotherapy groups, the median ages were 56 and 56 years, 46% and 45% of patients were male sex, 91% and 94% of patients had de novo AML, and 74% and 71% of patients had an intermediate cytogenetic risk status, respectively. All included patients were aged 18 to 75 years.

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The median follow-up was 39.2 months. At this point, the median OS was 31.9 months in the quizartinib group vs 15.1 months in the placebo group (hazard ratio, 0.78; P =.032), meeting the study’s primary endpoint.

Event-free survival rates were, however, similar between the 2 groups (hazard ratio, 0.92; P =.24).

All patients in the quizartinib group and 99% of patients in the placebo group had at least 1 adverse event; grade 3 adverse events occurred in 92% and 90% of patients, respectively. The most frequently noted serious events in the quizartinib group were febrile neutropenia (11%), pneumonia (6%), septic shock (4%), and sepsis (4%).

“The findings from QuANTUM-First show the potential to provide an effective and well tolerated treatment option for patients aged 18–75 years with FLT3-ITD-positive newly diagnosed AML,” the authors wrote in their report.

Disclosures: This research was supported by Daiichi Sankyo. Please see the original reference for a full list of disclosures.


Erba HP, Montesinos P, Kim HJ, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-83. doi:10.1016/S0140-6736(23)00464-6