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Therapy Name Ziftomenib
Synonyms
Therapy Description

Komzifti (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). Komzifti (ziftomenib) is FDA-approved for use in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible NPM1 mutation (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ziftomenib Komzifti KO539|KO 539|KO-539 MEN1-KMT2A Inhibitor 8 Komzifti (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). Komzifti (ziftomenib) is FDA-approved for use in patients with relapsed/refractory acute myeloid leukemia harboring a susceptible NPM1 mutation (FDA.gov).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • 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), Komzifti (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
NCT06440135 Phase I Ziftomenib Ziftomenib Maintenance Post Allo-HCT Recruiting USA 0
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 Ib/II Itraconazole + Ziftomenib Ziftomenib Midazolam + Ziftomenib First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Recruiting USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL 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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