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Astellas' Xospata Fails to Extend Survival in Phase III Newly Diagnosed AML Trial

NEW YORK – Astellas said on Monday that a Phase III trial evaluating gilteritinib (Xospata) as a treatment for FLT3-mutated acute myeloid leukemia failed to meet its primary overall survival endpoint.

In the Phase III LACEWING trial, Astellas was exploring how newly diagnosed, FLT3-mutated AML patients fared on gilteritinib, which is already approved in the US and elsewhere for refractory patients. The study, involving about 250 newly diagnosed AML patients, was comparing the activity of gilteritinib plus azacitidine versus azacitidine alone. Astellas plans to share detailed results from the trial at a later date.

An independent data monitoring committee recommended terminating the study after determining that it was unlikely to show that the addition of gilteritinib to azacitidine would enable patients to live longer compared to those receiving just azacitidine. As such, Astellas has stopped enrollment.

"These results do not affect other ongoing gilteritinib trials," Andrew Krivoshik, oncology therapeutic area head at Astellas, said in a statement. "We remain committed to our comprehensive program investigating gilteritinib across a wide range of AML patients with a positive FLT3 mutation, building on gilteritinib's earlier, positive data in patients with relapsed or refractory FLT3 mutation-positive AML."

The drug was approved by the European Medicines Agency last year for relapsed or refractory FLT3-mutated AML based on results of the randomized, Phase III ADMIRAL study, which showed an average overall survival of 9.3 months for those treated with gilteritinib compared to 5.6 months for patients on salvage chemotherapy. The US Food and Drug Administration approved gilteritinib for this same indication in 2018, and Chinese regulators accepted Astellas' NDA for the drug in this setting in April.

This year, the UK's National Institute for Health and Care Excellence (NICE) also recommended gilteritinib for relapsed or refractory FLT3-mutated AML patients in July.