Therapy Detail

Therapy Name Quizartinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Quizartinib AC220 FLT3 Inhibitor 50 KIT Inhibitor 50 PDGFR-alpha Inhibitor 7 RET Inhibitor 36 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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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 14 ins acute myeloid leukemia sensitive Quizartinib Phase I Actionable In a Phase I trial, acute myeloid leukemia (AML) pediatric patients harboring a FLT3-ITD mutation demonstrated a greater sensitivity to treatment with Quizartinib (AC220) when compared to AML patients with wild-type FLT3, resulting in three complete responses, four with stable disease, and a lower bone marrow blast cell count (PMID: 26920889). 26920889
FLT3 exon 14 ins acute myeloid leukemia sensitive Quizartinib Phase II Actionable In a Phase II trial, Quizartinib (AC220) treatment resulted in a composite complete remission (CCR) in 56% (63/112; 3 complete remission (CR)) of FLT3-ITD-positive patients vs. 36% (16/44; 1 CR) of FLT3-ITD-negative patients with relapsed/refractory acute myeloid leukemia (AML) after first-line therapy, and CCR in 46% (62/136; 5 CR) of FLT3-ITD-positive vs. 30% (12/40; 1 CR) in FLT3-ITD-negative patients with relapsed/refractory AML after salvage chemotherapy or transplant (PMID: 29859851; NCT00989261). 29859851
KIT D816V Advanced Solid Tumor resistant Quizartinib Preclinical Actionable In a preclinical study, transformed cells expressing KIT D816V demonstrated resistance to Quizartinib in culture (PMID: 23497317). 23497317
FLT3 exon 14 ins FLT3 A848P Advanced Solid Tumor decreased response Quizartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FLT3 ITD and A848P demonstrated reduced sensitivity to Quizartinib (AC220) in culture (PMID: 23392356). 23392356
CBL mutant bone marrow cancer sensitive Quizartinib Preclinical Actionable In a preclinical study, Quizartinib (AC220) reduced white blood cell counts and decreased myeloid cell invasion in a CBL mutant mouse model with myeloproliferative disorder (PMID: 22990016). 22990016
Unknown unknown acute myeloid leukemia not applicable Quizartinib Phase II Actionable In a Phase II trial, Quizartinib (AC220) treatment resulted in a composite complete remission (CCR) in 36% (16/44; 1 complete remission (CR)) of FLT3-ITD-negative patients vs. 56% (63/112; 3 CR) of FLT3-ITD-positive patients with relapsed/refractory acute myeloid leukemia (AML) after first-line therapy, and CCR in 30% (12/40; 1 CR) of FLT3-ITD-negative vs. 46% (62/136; 5 CR) in FLT3-ITD-positive patients with relapsed/refractory AML after salvage chemotherapy or transplant (PMID: 29859851; NCT00989261). 29859851
FLT3 exon 14 ins FLT3 Y842H Advanced Solid Tumor decreased response Quizartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FLT3 ITD and Y842H demonstrated reduced sensitivity to Quizartinib (AC220) in culture (PMID: 23392356). 23392356
FLT3 exon 14 ins FLT3 F691L Advanced Solid Tumor resistant Quizartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FLT3 ITD and F691L were resistant to Quizartinib (AC220) in culture (PMID: 23392356). 23392356
FLT3 Y599_D600insSTDNEYFYVDFREYEY acute myeloid leukemia predicted - sensitive Quizartinib Phase I Actionable In a Phase I clinical trial, patients with refractory or relapsed acute myeloid leukemia positive for FLT3-ITD demonstrated a 53% (9/17) response rate compared to a 14% (5/37) response rate in those patients negative for FLT3-ITD when treated with Quizartinib (AC220) (PMID: 24002496). 24002496
KIT D816V KIT V560G mast cell neoplasm resistant Quizartinib Preclinical Actionable In a preclinical study, KIT D816V conferred resistance to Quizartinib in a mast cell line harboring both KIT V560G and KIT D816V in culture (PMID: 23497317). 23497317
FLT3 exon 14 ins FLT3 F691I Advanced Solid Tumor resistant Quizartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FLT3 ITD and F691I were resistant to Quizartinib (AC220) in culture (PMID: 23392356). 23392356
FLT3 exon 14 ins FLT3 N676D Advanced Solid Tumor decreased response Quizartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells over expressing FLT3 ITD and N676D demonstrated reduced sensitivity to Quizartinib (AC220) in culture (PMID: 23392356). 23392356

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02668653 Phase III Cytarabine + Daunorubicin + Idarubicin Quizartinib Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) AML Recruiting
NCT02039726 Phase III Filgrastim Cytarabine + Fludarabine + Idarubicin Cytarabine + Etoposide + Mitoxantrone Quizartinib An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Active, not recruiting


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