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Phase III LACEWING trial of gilteritinib in combination with azacitidine fails to meet its primary endpoint

Dec 22, 2020

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


  • A potent oral inhibitor of FMS-like tyrosine kinase 3 (FLT3) with demonstrated activity against FLT3-internal tandem duplication and FLT3-tyrosine kinase domain mutations.
  • Previously approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of patients with relapsed/refractory FLT3-mutated AML.

LACEWING trial (NCT02752035)1,2

  • Randomized, open-label, multicenter trial of gilteritinib in combination with azacitidine in patients with newly diagnosed FLT3-mutated AML, who are ineligible for intensive induction chemotherapy.
  • 250 adult patients randomized 2:1 to receive gilteritinib in combination with azacitidine or azacitidine alone.
  • Dosage: Gilteritinib orally, daily (Day 1–28); azacitidine intravenous infusion or subcutaneous injection, daily for 7 days (Day 1–7); in 28-day cycles.  
  • Start date: August 1, 2016.
  • Primary end point: Overall survival.
  • Key secondary endpoints: Event-free survival, best response, complete remission (CR), composite CR, and CR with partial hematologic recovery.

  1. Astellas. Astellas reports XOSPATA® (gilteritinib) in combination with azacitidine did not meet endpoint of overall survival in newly diagnosed FLT3 mutation-positive acute myeloid leukemia patients ineligible for intensive induction chemotherapy. Published Dec 21, 2020. Accessed Dec 22, 2020.
  2. A study of ASP2215 (gilteritinib) by itself, ASP2215 combined with azacitidine or azacitidine by itself to treat adult patients who have recently been diagnosed with acute myeloid leukemia with a FLT3 gene mutation and who cannot receive standard chemotherapy. Updated Dec 19, 2020. Accessed Dec 22, 2020.