Gilteritinib superior in relapsed, refractory FLT3-mutated AML

(HealthDay)—For relapsed or refractory acute myeloid leukemia (AML) with mutations in the FMS-like tyrosine kinase 3 gene (FLT3), treatment with a selective FLT3 inhibitor, gilteritinib, results in significantly longer survival and a greater percentage of patients with remission than salvage chemotherapy, according to a study published in the Oct. 31 issue of the New England Journal of Medicine.

Alexander E. Perl, M.D., from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia, and colleagues randomly assigned adults with relapsed or refractory FLT3-mutated AML to receive either gilteritinib or salvage chemotherapy (247 and 124 patients, respectively) in a phase 3 trial.

The researchers found that median overall survival was significantly longer in the gilteritinib versus the chemotherapy group (9.3 versus 5.6 months; hazard ratio for death, 0.64; 95 percent confidence interval [CI], 0.49 to 0.83; P < 0.001). Median event-free survival was 2.8 and 0.7 months in the gilteritinib and chemotherapy groups, respectively (hazard ratio for treatment failure or death, 0.79; 95 percent CI, 0.58 to 1.09). Overall, 34.0 and 15.3 percent of patients in the gilteritinib and chemotherapy groups, respectively, had complete remission with full or partial hematologic recovery (risk difference, 18.6 percentage points; 95 percent CI, 9.8 to 27.4); 21.1 and 10.5 percent, respectively, had complete remission (risk difference, 10.6 percentage points; 95 percent CI, 2.8 to 18.4). After adjustment for therapy duration, in the gilteritinib group versus the chemotherapy group, adverse events of grade 3 or higher and serious adverse events occurred less frequently.

"We found that in this population of patients, gilteritinib resulted in superior overall survival and percentages of remission as compared with salvage chemotherapy," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Astellas Pharma, which manufactures gilteritinib and funded the study.

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