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An oral FLT3 inhibitor extended survival compared with salvage chemotherapy in relapsed AML with a FLT3 mutation, doubling the remission rate.
ADMIRAL randomised 371 adults with relapsed or refractory FLT3-mutated AML in a 2:1 ratio to gilteritinib 120 mg daily or investigator-chosen salvage chemotherapy (high- or low-intensity). Primary endpoints were overall survival and the rate of complete remission or remission with partial haematological recovery. Median OS was 9.3 versus 5.6 months (hazard ratio 0.64) and one-year survival 37.1% versus 16.7%; CR/CRh was 34.0% versus 15.3%. More patients on gilteritinib proceeded to transplant, and toxicity was lower than with chemotherapy. It established single-agent targeted therapy as a standard in relapsed FLT3-mutated AML.
ADMIRAL showed that a targeted oral drug can beat chemotherapy outright in relapsed AML, and made gilteritinib the standard bridge to transplant for FLT3-mutated relapse. Its success also underpinned FLT3 inhibitor use in first-line combinations. Resistance through FLT3-independent clones and RAS pathway mutations limits durability without transplant.
Shares Quizartinib, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, Midostaurin, Gilteritinib.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Astellas, Allogeneic stem cell transplantation.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Gilteritinib, FLT3-mutated acute myeloid leukaemia, Astellas, Acute myeloid leukaemia.
Shares Midostaurin, FLT3, Acute myeloid leukaemia.