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Astellas' Phase 3 Trial On Gilteritinib-Azacitidine Fails To Meet Primary Goal In FLT3mut+ AML

Astellas Pharma Inc.'s (ALPMY,ALPMY) Xospata or gilteritinib plus azacitidine compared to azacitidine alone in newly diagnosed FLT3 mutation-positive acute myeloid leukemia patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival, as per a phase 3 LACEWING trial.

An independent Data Monitoring Committee has recommended to terminate the study for futility, concluding that results are unlikely to show a statistically significant increase in overall survival.

Therefore, the company has stopped enrollment in the trial and is reviewing the results for other action as needed, Astellas said in a statement.

But the company noted that the results do not affect other ongoing gilteritinib trials.

The company said it remains committed to its 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 Phase 3 LACEWING trial, dubbed as NCT02752035, is an open-label, multicenter, randomized trial designed to evaluate gilteritinib plus azacitidine versus azacitidine alone in approximately 250 newly diagnosed FLT3mut+ AML patients who are ineligible for first-line intensive induction chemotherapy.

The primary endpoint was overall survival defined as the time from the date of randomization until the date of death from any cause. Key secondary endpoints include event-free survival, best response, complete remission, composite complete remission and complete remission with partial hematologic recovery.

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