Therapy Detail
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| Therapy Name | Azacitidine + Gilteritinib + Venetoclax |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
| Gilteritinib | Xospata | ASP2215 | AXL Inhibitor 30 FLT3 Inhibitor 66 | Xospata (gilteritinib) is a small molecule inhibitor of FLT3 and AXL that has activity against FLT3-ITD, FLT3 F691L, and FLT3 D835 mutations, potentially resulting in decreased tumor growth (J Clin Oncol 32:5s, 2014 (suppl; abstr 7070), PMID: 25891481). Xospata (gilteritinib) is FDA approved for use in patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (ITD, D835X, and I836X) (FDA.gov). |
| Venetoclax | Venclexta | ABT-199|RG7601|GDC-0199|ABT119|Venclyxto | BCL2 inhibitor 27 | Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 D835X | acute myeloid leukemia | sensitive | Azacitidine + Gilteritinib + Venetoclax | Phase Ib/II | Actionable | In a Phase I/II trial, Venclexta (venetoclax), Vidaza (azacitidine), and Xospata (gilteritinib) treatment demonstrated safety in acute myeloid leukemia patients with FLT3-ITD or FLT3 D835 mutations and led to a combined complete remission (CR)/CR with incomplete hematologic recovery (CR/CRi) rate of 96% and a median relapse-free survival and median overall survival not reached in newly diagnosed patients (n=30), and a CR/CRi rate of 27% in relapsed/refractory patients (n=22) (PMID: 38277619; NCT04140487). | 38277619 |
| FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Azacitidine + Gilteritinib + Venetoclax | Phase Ib/II | Actionable | In a Phase I/II trial, Venclexta (venetoclax), Vidaza (azacitidine), and Xospata (gilteritinib) treatment demonstrated safety in acute myeloid leukemia patients with FLT3-ITD or FLT3 D835 mutations and led to a combined complete remission (CR)/CR with incomplete hematologic recovery (CR/CRi) rate of 96% and a median relapse-free survival and median overall survival not reached in newly diagnosed patients (n=30), and a CR/CRi rate of 27% in relapsed/refractory patients (n=22) (PMID: 38277619; NCT04140487). | 38277619 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04140487 | Phase Ib/II | Azacitidine + Gilteritinib + Venetoclax | Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm | Active, not recruiting | USA | 0 |
| NCT05520567 | Phase Ib/II | Azacitidine + Gilteritinib + Venetoclax | A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia | Recruiting | USA | 0 |
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