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How Does Gilteritinib Compare With Chemotherapy for FLT3 -Mutated AML?

By: Kayci Reyer
Posted: Sunday, March 1, 2020

According to a phase III trial published in The New England Journal of Medicine, patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) who receive the FLT3 inhibitor gilteritinib experienced superior outcomes when compared with patients who received salvage chemotherapy. “Gilteritinib therapy led to higher percentages of patients with response and longer survival than salvage chemotherapy among patients with relapsed or refractory FLT3-mutated AML,” concluded Alexander E. Perl, MD, Associate Professor of Medicine of the University of Pennsylvania, and colleagues.

The trial included 371 patients with relapsed or refractory FLT3-mutated AML. Participants were randomly assigned in a 2:1 ratio to receive either 120 mg of gilteritinib daily (n = 247) or salvage chemotherapy (n = 124). The median overall survival and the median event-free survival were longer in the gilteritinib group than in the chemotherapy group (9.3 months vs. 5.6 months and 2.8 months vs. 0.79 months, respectively). The gilteritinib group also had a higher percentage of patients experiencing total remission with at least partial hematologic recovery (34.0% vs. 15.3%) as well as of those experiencing complete remission (21.1% vs. 10.5%).

The gilteritinib group experienced few serious adverse events with only grade 3 adverse events observed when outcomes were adjusted for the duration of therapy. Common adverse events included febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).

“Trials of gilteritinib as part of first-line induction or consolidation therapy and as postconsolidation or post-transplantation maintenance therapy (ClinicalTrials.gov identifiers NCT02927262, NCT02997202, and NCT02752035) are under way to assess the role of timing of anti-FLT3 intervention in improving treatment outcomes,” the investigators concluded.

Disclosure: For full disclosures of the study authors, visit nejm.org.


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