Astellas Pharma has reported positive results from a Phase l study evaluating gilteritinib in combination with intensive chemotherapy in patients newly diagnosed with acute myeloid leukemia (AML).

The ongoing trial is an open-label, dose escalation/expansion study that enrolled 50 patients until July this year.

The study’s primary endpoint is to evaluate the safety/tolerability profile, including dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD), of gilteritinib when combined with 7+3 induction and high-dose cytarabine (HiDAC) consolidation chemotherapy.

This would be followed by single-agent maintenance therapy in patients 18 years of age and older who have been newly diagnosed with AML.

The two-part study also includes an objective of assessing the antitumor effects of this combination therapy.

It first enrolled patients to successive cohorts to determine the MTD, while successive cohorts received daily gilteritinib doses of 40mg, 80mg or 120mg.

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Patients in the dose expansion cohort of the trial received gilteritinib at the recommended expansion dose established during dose escalation.

“This initial data sheds encouraging light on the safety and tolerability of gilteritinib when combined with intensive chemotherapy for newly diagnosed AML patients.”

The enrolled patients also received gilteritinib during consolidation and then maintenance therapy with once-daily gilteritinib over a 28-day cycle for up to 26 cycles.

During the trial, 49 had received at least one dose of gilteritinib, while 23 and of 13 patients of the 48 patients who documented FLT3 mutation status were found to be FLT3mut+ and had internal tandem duplications (ITD) respectively.

Keith Pratz of John Hopkins Sidney Kimmel Comprehensive Cancer Center is the principal investigator for the study.

Pratz said: “These initial data shed encouraging light on the safety and tolerability of gilteritinib when combined with intensive chemotherapy for newly diagnosed AML patients.

“In addition, while evaluating antitumor effects is an exploratory goal, the response rates in FLT3mut+ patients are promising and warrant expanded investigation of gilteritinib in this upfront treatment setting.”

The gilteritinib has previously demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in around one-third of patients with AML.