Ps1024 Impact of Minimal Residual Disease and Complete Remission (Cr)/Cr With Partial Hematologic Recovery on Survival After Gilteritinib Therapy in Patients With Flt3-Mutated Relapsed/Refractory Aml

Abstract

included electrocardiogram (ECG) QT prolonged (26%), IDH differentiation syndrome (17%), and leukocytosis (13%). Grade 3/4 AEs in ≥10% of patients were thrombocytopenia (61%), anemia (44%), febrile neutropenia (39%), neutropenia (26%), sepsis (22%), and ECG QT prolonged (13%). ORR was 78% (n = 18), including a CR rate of 57%, a CRi/CRp rate of 13%, and an MLFS rate of 9%. The CR+CRh rate was 70% (n = 16). Median time to response was 1.8 months (range, 0.7-3.8) and to CR was 3.5 months (range, 0.8-6.0); median response duration not yet reached. mIDH1 clearance was seen in 10 of 16 patients (63%) with CR/CRh, including 9 of 13 (69%) with CR. Summary/Conclusion: IVO+AZA was well tolerated, and had a safety profile consistent with IVO or AZA monotherapy. All-grade cytopenia-related AEs were infrequent relative to other nonintensive therapies. CR rate and ORR exceeded those of AZA alone (Dombret et al. Blood 2015) and a majority of responders achieved mIDH1 mutation clearance. Based on these findings, a phase 3 double-blind placebo-controlled study of IVO+AZA (AGILE, NCT03173248) is actively enrolling patients.