Therapy Detail
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| Therapy Name | CUDC-907 + Gilteritinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| CUDC-907 | Fimepinostat | HDAC Inhibitor 45 PI3K Inhibitor (Pan) 42 | CUDC-907 (fimepinostat) is a dual PI3K and HDAC inhibitor, which prevents activation of the PI3K-AKT-mTOR signal transduction pathway, inhibits tumor cell growth, and promotes apoptosis in cancer cells (PMID: 22693356, PMID: 32459381). | |
| Gilteritinib | Xospata | ASP2215 | AXL Inhibitor 30 FLT3 Inhibitor 69 | 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). |
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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 | CUDC-907 + Gilteritinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination of CUDC-907 (fimepinostat) and Xospata (gilteritinib) synergistically inhibited cell growth, decreased Flt3 signaling, and induced apoptosis in patient-derived acute myeloid leukemia cells harboring FLT3-ITD mutations in culture, and resulted in prolonged survival compared to either agent alone in cell line xenograft models (PMID: 34099621). | 34099621 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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