Astellas reports Xospata + azacitidine did not meet the endpoint of overall survival in newly diagnosed FLT3 mutation-positive acute myeloid leukemia.

Astellas Pharma Inc. announced that a Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival > at a planned interim analysis of the LACEWING trial. An independent Data Monitoring Committee recommended terminating the study for futility, concluding results are unlikely to show a statistically significant increase in overall survival . Astellas has stopped enrollment in the trial and is reviewing the results for other action as needed.