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On December 21, 2020, it was announced that the phase III LACEWING trial (NCT02752035) failed to meet its primary endpoint of a statistically significant improvement in overall survival with gilteritinib plus azacitidine, versus azacitidine alone, in patients with newly diagnosed, FLT3-mutated acute myeloid leukemia (AML), who were ineligible for intensive induction chemotherapy.1
Based on the results of this planned interim analysis, an independent data monitoring committee recommended terminating the study. Therefore, enrolment to the trial has ceased. A thorough review of the data has commenced, with results to be published in due course.1
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