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AML19 trial Midotarg substudy: Gemtuzumab ozogamicin + midostaurin in FLT3-mutated AML
Results from the Midotarg substudy of the phase III AML19 trial (ISRCTN78449203), evaluating the efficacy and safety of gemtuzumab ozogamicin (GO) and midostaurin (m) in combination with daunorubicin and cytarabine (DA) in 77 patients aged <60 with newly diagnosed FLT3-mutated acute myeloid leukemia (AML), were published by Russell et al. in Blood Advances.
Key data: The overall response rate (ORR) was 91% in all patients after two induction cycles. The 2-year overall survival (OS), event-free survival (EFS), and cumulative incidence of relapse (CIR) rates were 77%, 62%, and 31%, respectively. Among evaluable patients, 81% were NPM1-measurable residual disease (MRD) negative, and all patients had FLT3-MRD levels <0.01%. DAGO + m was well tolerated with 0% mortality at Day 30 and 60, with no increased toxicity.
Key learning: The Midotarg substudy demonstrated that DAGO + m was safe and effective in younger patients with newly diagnosed FLT3-mutated AML. DAGO + m is currently being evaluated in a randomized phase II/III trial (OPTIMISE-FLT3).
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