Therapy Detail
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| Therapy Name | Ziftomenib |
| Synonyms | |
| Therapy Description |
Ziftomenib is a small molecule inhibitor of MEN1 (menin)-KMT2A (MLL1) complex, which may lead to decreased growth KMT2A (MLL1)-positive tumor cells, and inhibition of tumor growth (PMID: 36151141). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ziftomenib | KO539|KO 539|KO-539 | MEN1-KMT2A Inhibitor 8 | Ziftomenib is a small molecule inhibitor of MEN1 (menin)-KMT2A (MLL1) complex, which may lead to decreased growth KMT2A (MLL1)-positive tumor cells, and inhibition of tumor growth (PMID: 36151141). |
Filtering
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- Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
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- Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| KMT2A rearrange | acute myeloid leukemia | no benefit | Ziftomenib | Phase I | Actionable | In a Phase Ib trial (KOMET-001), Ziftomenib treatment resulted in an overall response rate of 17% (3/18) and a complete remission or complete remission with partial hematologic recovery rate of 11% (2/18) at the recommended Phase II dose level in acute myeloid leukemia patients harboring KMT2A rearrangements, but enrollment was halted due to increased frequency of differentiation syndrome (PMID: 39362248; NCT04067336). | 39362248 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06930352 | Phase II | Ziftomenib | Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy | Not yet recruiting | USA | 0 |
| NCT04067336 | Phase I | Ziftomenib | First in Human Study of KO-539 in Relapsed or Refractory Acute Myeloid Leukemia | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 0 |
| NCT06440135 | Phase I | Ziftomenib | Ziftomenib Maintenance Post Allo-HCT | Recruiting | USA | 0 |
| NCT06376162 | Phase I | Ziftomenib Cytarabine + Fludarabine + Ziftomenib | Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia | Recruiting | USA | CAN | 0 |
| NCT05848687 | Phase Ib/II | Bortezomib Dexamethasone Blinatumomab Vorinostat Mercaptopurine Pegaspargase Methotrexate Ziftomenib Mitoxantrone | TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II | Recruiting | USA | CAN | 0 |
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