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Therapy Name Milademetan + Quizartinib
Synonyms
Therapy Description

Quizartinib (AC220) targets both wild-type and mutant FLT3 containing activating internal tandem duplications, as well as PDGFRA, RET, and KIT, which may induce apoptosis and inhibit tumor growth (PMID: 19654408, PMID: 23497317).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Milademetan DS-3032b|Milademetan Tosylate|DS3032b|DS 3032b|RAIN-32 MDM2 Inhibitor 23 Milademetan binds to MDM2 and prevents binding to p53, resulting in activation of p53 signaling and increased tumor cell apoptosis (PMID: 29416773, PMID: 32651541).
Quizartinib Vanflyta AC220 FLT3 Inhibitor 69 Vanflyta (quizartinib) is a small molecule that selectively inhibits FLT3, which may induce apoptosis and inhibit tumor growth (PMID: 19654408, PMID: 23497317). Vanflyta (quizartinib) is FDA-approved for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, in patients with newly diagnosed acute myeloid leukemia harboring FLT3 ITD mutations (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins TP53 wild-type acute myeloid leukemia sensitive Milademetan + Quizartinib Phase I Actionable In a Phase I trial, combination of Vanflyta (quizartinib) and Milademetan led to a complete response with incomplete hematologic recovery (CRi) in 40% (4/10) and stable disease (SD) in 30% of patients with TP53 wild-type acute myeloid leukemia harboring a FLT3-ITD, with a CRi of 50% (3/6) at the recommended dose; and the combination inhibited Flt3 signaling and synergistically induced apoptosis in culture and decreased leukemia growth in a cell line xenograft model (PMID: 40327322; NCT03552029). 40327322
FLT3 exon 14 ins FLT3 D835Y TP53 wild-type acute myeloid leukemia sensitive Milademetan + Quizartinib Preclinical - Pdx Actionable In a preclinical study, treatment with the combination of Vanflyta (quizartinib) and Milademetan decreased leukemia burden and improved survival compared to either drug alone in a patient-derived xenograft (PDX) model of TP53 wild-type acute myeloid leukemia harboring a FLT3-ITD mutation and FLT3 D835Y (PMID: 40327322). 40327322

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03552029 Phase I Milademetan + Quizartinib Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) Terminated USA 0


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