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Adding the FLT3 inhibitor quizartinib to standard chemotherapy, and continuing it for up to three years, roughly doubled median survival in FLT3-ITD acute myeloid leukaemia.
QuANTUM-First randomised 539 adults aged 18-75 with newly diagnosed FLT3-ITD-positive AML to quizartinib or placebo added to standard 7+3 induction and consolidation, continued after allogeneic transplant where performed, and then as maintenance for up to 36 cycles. The primary endpoint was overall survival. Median OS was 31.9 versus 15.1 months (hazard ratio 0.78), with similar remission rates but lower relapse in the quizartinib arm. QT prolongation and cytopenias were more frequent with quizartinib. It followed RATIFY (midostaurin) as the second phase 3 trial to show a survival benefit from a FLT3 inhibitor in front-line therapy, and the first with a selective type II inhibitor.
QuANTUM-First gave FLT3-ITD AML patients a second front-line targeted option and showed that continuing a FLT3 inhibitor as long-term maintenance, including after transplant, pays off. Quizartinib was approved for this indication in 2023. Head-to-head data against midostaurin are lacking, and the design leaves open how much of the benefit came from maintenance.
Shares Richard M. Stone, FLT3 inhibitor + intensive chemotherapy, Cytarabine + anthracycline ('7+3'), Midostaurin.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, Gilteritinib, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, FLT3-mutated acute myeloid leukaemia, Daiichi Sankyo, Acute myeloid leukaemia.
Shares Midostaurin, Gilteritinib, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares Midostaurin, FLT3, Acute myeloid leukaemia.