Eunice S Wang, Pau Montesinos, Mark D Minden, Hassan Sibai, Je-Hwan Lee, Michael Heuser, Tomoki Naoe, Wen-Chien Chou, Kamel Laribi, Jordi Esteve, Jessica K Altman, Violaine Havelange, Anne-Marie Watson, Monica Fumagalli, Elzbieta Patkowska, Jason E Hill, Stanley C Gill, Bhavik J Pandya, Caroline Chen, Nahla Hasabou
The phase 3, open-label LACEWING study evaluated efficacy and safety of the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib (GIL) plus azacitidine (AZA) in newly diagnosed (ND) FLT3-mutated (FLT3mut+) acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy (IIC). Patients were enrolled into a safety cohort (n=15) or randomized (n=168) to GIL+AZA, GIL, or AZA. We present final (6.5-year) outcomes and additional data on mutational subgroups, measurable residual disease (MRD), and pharmacokinetics. Median overall survival (OS) was 9.82 versus 9.23 months (GIL+AZA vs AZA, p=0.182) and 5.24 months (GIL). Corresponding two-year OS rates were 18.8%, 12.9%, and 4.5%. Overall response rates were 70.2% versus 36.8% (GIL+AZA vs AZA, nominal p.