Bone marrow aspirate showing acute myeloid leukemia. Credit: VashiDonsk at English Wikipedia.

Daiichi Sankyo Company has dosed the first patient in the first in a Phase I trial evaluating the safety and activity of quizartinib in combination with milademetan (DS-3032) to treat patients with relapsed / refractory FLT3-ITD acute myeloid leukemia (AML).

The multi-centre, non-randomised, open-label trial will be conducted in two parts and will include newly-diagnosed FLT3-ITD AML patients who are unfit for intensive chemotherapy.

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Part one of the study (dose escalation) will investigate the safety and tolerability of the drug combination to establish the dosing schedule, maximum tolerated dose and recommended dose for expansion.

The trial’s second part (dose expansion) will validate the safety and tolerability at the recommended dose for expansion of the study drug combination. This phase will also identify a recommended Phase II dose.

“We also are exploring the potential of the combination of quizartinib and milademetan in patients with newly-diagnosed FLT3-ITD AML who are unfit for intensive chemotherapy.”

Primary endpoint of the trial is safety, while its secondary endpoints include pharmacokinetics and preliminary efficacy.

Daiichi Sankyo aims to enrol around 110 patients in the US, Europe and Japan.

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Daiichi Sankyo Oncology research and development vice-president Arnaud Lesegretain said: “We have initiated this combination study of quizartinib and milademetan in order to determine the safety and tolerability of the combination and if the addition of the MDM2 inhibitor milademetan may potentially further improve the outcomes of patients with relapsed / refractory FLT3-ITD AML beyond what has been previously reported with single agent quizartinib.

“In this study, we also are exploring the potential of the combination of quizartinib and milademetan in patients with newly-diagnosed FLT3-ITD AML who are unfit for intensive chemotherapy.”

Quizartinib is a FMS-like tyrosine kinase 3 (FLT3) inhibitor, while milademetan is a mouse double minute 2 homolog (MDM2) inhibitor.