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    DRUG CLASS:

    MLL1 inhibitor

    Associations

    News

    Trials
    6ms
    CR108998: A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (clinicaltrials.gov)
    P1/2, N=400, Recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2027 --> May 2028
    Trial completion date
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    bleximenib (JNJ-6617)
    6ms
    KOMET-001: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=263, Recruiting, Kura Oncology, Inc. | N=199 --> 263
    Enrollment change
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
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    NPM1 mutation • KMT2A rearrangement
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    Komzifti (ziftomenib) • Onmel (itraconazole) • Tolsura (SUBA-itraconazole)
    7ms
    CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
    P1, N=200, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2026 --> Oct 2024
    Trial primary completion date
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
    8ms
    KOMET-001: First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=199, Recruiting, Kura Oncology, Inc. | Trial completion date: Sep 2025 --> Oct 2028 | Trial primary completion date: Sep 2024 --> Oct 2028
    Trial completion date • Trial primary completion date
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    NPM1 mutation • KMT2A rearrangement
    |
    Komzifti (ziftomenib)
    9ms
    CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
    P1, N=200, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Mar 2025 --> Aug 2026
    Trial primary completion date
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
    10ms
    cAMeLot-2: A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P3, N=600, Not yet recruiting, Janssen Research & Development, LLC
    New P3 trial
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    Venclexta (venetoclax) • azacitidine • bleximenib (JNJ-6617)
    11ms
    Targeting the Menin-KMT2A interaction in leukemia: Lessons learned and future directions. (PubMed, Int J Cancer)
    Indeed, one Menin inhibitor, Revumenib, was recently approved for the treatment of patients with relapsed or refractory KMT2A-rearranged acute leukemia. However, single agent therapy can lead to resistance. In this Review article we summarize our current understanding about the biology of pathogenic KMT2A-complex function in cancer, specifically leukemia, and give a systematic overview of lessons learned from recent clinical and preclinical studies using Menin inhibitors.
    Review • Journal
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    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • AFF1 (AF4/FMR2 Family Member 1) • MLLT3 (MLLT3 Super Elongation Complex Subunit) • MLLT10 (MLLT10 Histone Lysine Methyltransferase DOT1L Cofactor)
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    NPM1 mutation • KMT2A rearrangement
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    Revuforj (revumenib) • Komzifti (ziftomenib) • bleximenib (JNJ-6617)
    11ms
    CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
    P1, N=200, Recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2026 --> Mar 2027
    Trial completion date
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
    12ms
    Bleximenib, the novel menin-KMT2A inhibitor JNJ-75276617, impairs long-term proliferation and immune evasion in acute myeloid leukemia. (PubMed, Haematologica)
    Functionally, this results in enhanced sensitivity of leukemic blasts to T cell-mediated cytotoxicity in allogeneic and autologous settings. Our data indicate that JNJ-75276617 provides a potential therapeutic approach whereby not only proliferation is impaired and differentiation is induced, but whereby therapeutic benefit might also be achieved by reactivating the antigen presentation machinery.
    Journal
    |
    DNMT3A (DNA methyltransferase 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1) • MLLT3 (MLLT3 Super Elongation Complex Subunit)
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    NPM1 mutation • MLL rearrangement
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    bleximenib (JNJ-6617)
    1year
    Pyoderma gangrenosum-like neutrophilic dermatosis as an adverse effect of menin-KMT2A inhibitor therapy for acute myeloid leukaemia. (PubMed, Ann Hematol)
    A 71 years old woman received the MENi revumenib (REV) for relapsed/refractory NPM1m AML...However, to our knowledge, this is the first report ever of MENi induced PG-like ND and cutaneous involvement of DS. This report highlights the fact that ND such as PG, as a manifestation of DS, are a possibly severe adverse effect of MENi.
    Journal • Adverse events
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    KMT2A (Lysine Methyltransferase 2A)
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    Revuforj (revumenib)
    1year
    CR109124: A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (clinicaltrials.gov)
    P1, N=200, Recruiting, Janssen Research & Development, LLC | N=150 --> 200
    Enrollment change • Combination therapy
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • bleximenib (JNJ-6617)
    over1year
    A Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias (clinicaltrials.gov)
    P1, N=0, Withdrawn, Janssen Research & Development, LLC | N=80 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NUP214 (Nucleoporin 214)
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    cytarabine • vincristine • Oncaspar liquid (pegaspargase) • fludarabine IV • bleximenib (JNJ-6617)