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    DRUG CLASS:

    Menin-MLL inhibitor

    Related drugs:
    17h
    A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, M.D. Anderson Cancer Center | Initiation date: May 2026 --> Nov 2026
    Trial initiation date
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    KMT2A (Lysine Methyltransferase 2A)
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    clonoSEQ®
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    Revuforj (revumenib)
    6d
    Revumenib-Induced QTc Prolongation Leading to Multiple Episodes of Torsades de Pointes and Ventricular Arrhythmias. (PubMed, Ochsner J)
    Despite a subsequent episode of torsades de pointes, the patient continued revumenib for an additional 29 days without further arrhythmias until discontinuation because of worsening acute myeloid leukemia shown by bone marrow biopsy. Although current guidance recommends discontinuation of revumenib in the setting of life-threatening arrhythmias, this case highlights the importance of individualized risk-benefit assessment and supportive strategies when treatment is pursued as a last resort.
    Journal
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    KMT2A (Lysine Methyltransferase 2A)
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    Revuforj (revumenib)
    13d
    The All-Oral Combination of Revumenib, Decitabine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (SAVE). (PubMed, J Clin Oncol)
    This combination was associated with high response rates and durable remissions, with an acceptable safety, in heavily pretreated patients with AML harboring alterations susceptible to menin inhibition.
    Journal • IO biomarker
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2)
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    NPM1 mutation • KMT2A rearrangement
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    Venclexta (venetoclax) • Revuforj (revumenib) • Inqovi (decitabine/cedazuridine)
    13d
    ETCTN 10596: A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease (clinicaltrials.gov)
    P1, N=38, Recruiting, National Cancer Institute (NCI) | N=28 --> 38
    Enrollment change
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    FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • CD33 (CD33 Molecule)
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    FLT3-ITD mutation • FLT3 mutation • NPM1 mutation
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    daunorubicin • Revuforj (revumenib) • Starasid (cytarabine ocfosfate)
    15d
    Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Treatment (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, SWOG Cancer Research Network
    New P2 trial
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    CD19 (CD19 Molecule) • KMT2A (Lysine Methyltransferase 2A)
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    clonoSEQ®
    |
    cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • Revuforj (revumenib) • leucovorin calcium • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    21d
    A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=6, Recruiting, Kyowa Kirin Co., Ltd.
    New P2 trial
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    NPM1 (Nucleophosmin 1)
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    Komzifti (ziftomenib)
    22d
    Ziftomenib with venetoclax and azacitidine in relapsed/refractory NPM1-mutated acute myeloid leukemia. (PubMed, Blood)
    The combination of ziftomenib 600 mg with venetoclax/azacitidine was well tolerated with deep and durable clinical activity in R/R NPM1-m AML. This trial was registered at www.ClinicalTrials.gov as #NCT05735184.
    Journal
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    NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
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    Venclexta (venetoclax) • azacitidine • Komzifti (ziftomenib)
    26d
    A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients (clinicaltrials.gov)
    P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=32 --> 0 | Trial completion date: Dec 2034 --> May 2026 | Initiation date: Dec 2027 --> May 2026 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2032 --> May 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial withdrawal • Trial primary completion date
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    KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2)
    |
    cytarabine • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Revuforj (revumenib)
    29d
    RAVEN: Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML (clinicaltrials.gov)
    P2, N=88, Not yet recruiting, UNC Lineberger Comprehensive Cancer Center
    New P2 trial
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    Venclexta (venetoclax) • azacitidine • Revuforj (revumenib)
    1m
    Blocking SETD2 Enhances the Therapeutic Efficiency of Menin Inhibitor in MLL-Fusion Leukemia. (PubMed, Cancer Sci)
    Next, we show that inhibitors of SETD2 (EZM0414) and menin (Revumenib) have synergistic efficacy against MLL-fusion and NPM1-mut leukemia and make prominent induction of cell cycle arrest, differentiation, and apoptosis. Finally, we clarify that the combined-drug treatment delays MLL-fusion leukemia progression in vivo. Taken together, these findings establish the simultaneously blocking of transcription elongation and initiation by epigenetic inhibitors as a promising therapeutic strategy for these aggressive leukemias.
    Journal
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    NPM1 (Nucleophosmin 1) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase)
    |
    NPM1 mutation
    |
    Revuforj (revumenib) • IPN60210
    1m
    KOMET-001: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=263, Active, not recruiting, Kura Oncology, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • First-in-human
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1)
    |
    NPM1 mutation • KMT2A rearrangement
    |
    Komzifti (ziftomenib) • Onmel (itraconazole) • Tolsura (SUBA-itraconazole)
    1m
    Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients. (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Eilean Therapeutics | Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2026 --> Apr 2026
    Enrollment closed • Trial primary completion date