Astellas initiates Phase III trial for gilteritinib in AML

Astellas has announced an open-label, multicentre, randomised Phase III study of gilteritinib versus salvage chemotherapy in patients with acute myeloid leukemia (AML). The study will enroll 369 patients with FLT3 activating mutation in bone marrow or whole blood (as determined by central lab) AML who are refractory to or have relapsed after first-line AML therapy.

Subjects will be randomised in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy consisting of LoDAC (low-dose cytarabine), azacitidine, MEC (mitoxantrone, etoposide, and intermediate-dose cytarabine), or FLAG-IDA (fludarabine, cytarabine, and granulocyte colony-stimulating factor with idarubicin). The primary endpoint of the trial is overall survival.

For more information about this trial go to www.clinicaltrials.gov, trial identifier NCT02421939.