Paper: Phase 3, Open-Label, Randomized Study of Gilteritinib and Azacitidine Vs Azacitidine for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in Patients Ineligible for Intensive Induction Chemotherapy
In a randomized trial in FLT3 AML ineligible for intensive chemotherapy gilteritinib + AZA did not show an OS benefit vs. AZA alone. CR rates for both arms were similar (16.2% vs 14.3%), CRc rates were significantly higher for GIL+AZA vs AZA (58.1 vs 26.5%). Significantly more patients (44 v 20%) received subsequent AML therapy in the AZA alone arm, which may help explain the lack of OS benefit despite the 31% increase in CRc with Gil.
