Acute Myeloid Leukemia Coverage From Every Angle

ASH 2021: Gilteritinib and Azacitidine in FLT3-Mutated AML

By: Lauren Harrison, MS
Posted: Friday, December 17, 2021

Combining the FLT3 inhibitor gilteritinib with azacitidine led to a significant improvement in composite complete response rates over azacitidine alone among patients with newly diagnosed FLT3-mutated acute myeloid leukemia (AML), in a phase III trial. Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, New York, presented these findings at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 700).

This trial enrolled 123 patients with newly diagnosed FLT3-mutated AML who were unable to receive intensive induction chemotherapy. Patients were randomly assigned 2:1 to undergo treatment with either 120 mg of oral gilteritinib plus 75 mg/m2 injections of azacitidine daily or azacitidine alone during 28-day cycles. Treatment failure was defined as a lack of complete remission after six cycles.

The median duration of follow-up was 9.8 months for gilteritinib and azacitidine and 18.0 months for azacitidine alone. The median overall survival was 9.8 months with dual therapy and 8.9 months with the single treatment (P = .753). However, among patients with Eastern Cooperative Oncology Group performance scores of 0 or 1 as well as those with high FLT3-ITD ratios, overall survival was improved with combination therapy (hazard ratio = 0.811 and 0.580, respectively). Composite complete response rates were significantly higher with gilteritinib and azacitidine (58.1%) compared with azacitidine alone (26.5%). In the gilteritinib-plus-azacitidine arm, 20.3% of patients received subsequent therapy for AML, compared with 44.9% in the azacytidine-alone arm.

Grade 3 or higher adverse events occurred in 95.9% and 89.4% of patients in the combination and single therapy groups, respectively. Treatment-related adverse events resulted in deaths in four patients in each treatment arm. The most common adverse events seen with gilteritinib and azacitidine were pyrexia (47.9%) and diarrhea (38.4%).

Disclosure: For a full list of authors’ disclosures, visit

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