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    DRUG CLASS:

    Menin-MLL inhibitor

    Related drugs:
    1d
    CRISPR base editor screening identifies spectrum of MEN1 mutations impacting menin inhibitors in clinical trials. (PubMed, Nat Commun)
    CRISPR base editor screening previously predicted several MEN1 (menin) mutations that have arisen in patients receiving SNDX-5613 and confer resistance...Co-crystal structures of menin bound to each menin inhibitor suggest resistance mechanisms related to how each inhibitor engages the KMT2A binding pocket of menin. Orthogonal in vitro and in vivo MEN1 mutation generation under therapeutic pressure suggest the MEN1 mutations identified with CRISPR base editor screening are likely to arise and impact all menin inhibitors.
    Journal
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEN1 (Menin 1)
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    NPM1 mutation
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    Revuforj (revumenib)
    4d
    A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (clinicaltrials.gov)
    P1, N=0, Withdrawn, Children's Oncology Group | N=29 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
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    KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • CD4 (CD4 Molecule)
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    KMT2A rearrangement
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    cytarabine • methotrexate • Revuforj (revumenib) • Starasid (cytarabine ocfosfate)
    5d
    Combining Menin and MEK inhibition to target poor prognosis KMT2A-rearranged RAS pathway-mutant acute myeloid leukemia. (PubMed, Blood Adv)
    We evaluated RAS/MAPK targeting using the MEK1/2 inhibitor selumetinib in combination with the menin inhibitor revumenib. Our preclinical study suggests a potential targeted treatment combination for KMT2A-r and RAS pathway mutant leukemia, but one which will require further optimization. COG completed clinical trials AAML03P1, AAML0531, AAML1031 and C2961.
    Journal
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    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • KMT2A (Lysine Methyltransferase 2A)
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    RAS mutation • KMT2A mutation • MLL mutation
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    Koselugo (selumetinib) • Revuforj (revumenib)
    5d
    Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=24, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Jul 2026 --> Oct 2026
    Trial primary completion date
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214) • KAT6A (Lysine Acetyltransferase 6A) • MLLT10 (MLLT10 Histone Lysine Methyltransferase DOT1L Cofactor)
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    NPM1 mutation • KMT2A rearrangement
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    Venclexta (venetoclax) • cytarabine • azacitidine • methotrexate • Revuforj (revumenib)
    5d
    Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    The modeling results demonstrated a wide therapeutic margin for ziftomenib in adult R/R NPM1-m AML patients and supported a dose of 600 mg once daily in this patient population. Additionally, ER analyses demonstrated that antifungal azoles had no clinically meaningful impact on efficacy or safety profiles and thus could be co-administered with ziftomenib.
    PK/PD data • Journal
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
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    NPM1 mutation
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    Komzifti (ziftomenib)
    5d
    CR108998: A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jun 2026 --> Feb 2027
    Trial primary completion date • First-in-human
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
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    NPM1 mutation
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    bleximenib (JNJ-6617)
    6d
    REVEAL-ND NPM1: Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation (clinicaltrials.gov)
    P3, N=468, Recruiting, Syndax Pharmaceuticals
    Trial initiation date
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    NPM1 (Nucleophosmin 1)
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    NPM1 mutation
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    cytarabine • Revuforj (revumenib)
    9d
    Menin-Inhibitor Targeted Maintenance in AML (clinicaltrials.gov)
    P2, N=144, Not yet recruiting, Center for International Blood and Marrow Transplant Research
    New P2 trial
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    FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2)
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    FLT3-ITD mutation • NPM1 mutation
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    Revuforj (revumenib)
    10d
    Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P3, N=875, Recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland | N=423 --> 875
    Enrollment change • Trial initiation date
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    NPM1 mutation
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    cytarabine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
    15d
    MOMENTUM: Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression (clinicaltrials.gov)
    P1/2, N=84, Recruiting, AstraZeneca
    Trial initiation date • First-in-human
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    KMT2A (Lysine Methyltransferase 2A)
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    Noxafil (posaconazole)
    19d
    Sequential Transformation of Polycythemia Vera to Myelofibrosis and KMT2A-Rearranged Acute Myeloid Leukemia Treated With Revumenib: A Rare Case of Clonal Evolution. (PubMed, Cureus)
    He was initially treated with azacitidine and venetoclax but demonstrated disease progression. In the setting of a KMT2A::ELL fusion, therapy was transitioned to the menin inhibitor revumenib, resulting in short-term clinical stability and tolerability under continued supportive care.
    Journal
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    JAK2 (Janus kinase 2) • KMT2A (Lysine Methyltransferase 2A)
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    Venclexta (venetoclax) • azacitidine • Revuforj (revumenib)
    25d
    CR108998: A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (clinicaltrials.gov)
    P1/2, N=420, Recruiting, Janssen Research & Development, LLC | Trial completion date: May 2028 --> Sep 2030 | Trial primary completion date: Feb 2026 --> Jun 2026
    Trial completion date • Trial primary completion date • First-in-human
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
    |
    NPM1 mutation
    |
    bleximenib (JNJ-6617)