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    DRUG:

    icovamenib (BMF-219)

    i
    Other names: BMF-219
    Company:
    Biomea Fusion
    Drug class:
    Menin-MLL inhibitor
    Related drugs:
    7d
    Food Effect Study in Healthy Volunteers (clinicaltrials.gov)
    P1, N=60, Recruiting, Biomea Fusion Inc.
    New P1 trial
    |
    icovamenib (BMF-219)
    3ms
    BF-MNN-112: Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus (clinicaltrials.gov)
    P2, N=37, Terminated, Biomea Fusion Inc. | Active, not recruiting --> Terminated; Sponsor made a business decision to terminate the study based on prioritization of portfolio.
    Trial termination
    |
    icovamenib (BMF-219)
    3ms
    COVALENT-111: Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D) (clinicaltrials.gov)
    P1/2, N=443, Completed, Biomea Fusion Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    icovamenib (BMF-219)
    4ms
    Therapeutic Implications of Menin Inhibitors in the Treatment of Acute Leukemia: A Critical Review. (PubMed, Diseases)
    Currently, six menin inhibitors are in clinical evaluation as monotherapy or in combination regimens: revumenib, ziftomenib, bleximenib (previously JNJ-75276617), enzomenib (previously DSP-5336), DS-1594, and BMF-219. We discuss their efficacy, safety profiles, and potential roles within the current treatment algorithm. The continued clinical evaluation of menin inhibitors may redefine treatment paradigms for NPM1m and KMT2Ar AML and other acute leukemia with the aberrant MEIS1-HOXA axis, offering new hope for patients with limited therapeutic options.
    Review • Journal
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEIS1 (Meis Homeobox 1)
    |
    NPM1 mutation • KMT2A rearrangement • MLL mutation
    |
    Revuforj (revumenib) • Komzifti (ziftomenib) • icovamenib (BMF-219) • bleximenib (JNJ-6617) • emilumenib succinate (DS-1594) • enzomenib (DSP-5336)
    5ms
    BF-MNN-112: Phase 2 Trial of BMF-219 in Participants With Type 1 Diabetes Mellitus (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Biomea Fusion Inc. | N=190 --> 37 | Trial primary completion date: Aug 2025 --> May 2025
    Enrollment change • Trial primary completion date
    |
    icovamenib (BMF-219)
    5ms
    COVALENT-101: Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL (clinicaltrials.gov)
    P1, N=55, Terminated, Biomea Fusion Inc. | Active, not recruiting --> Terminated; Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.
    Trial termination
    |
    icovamenib (BMF-219)
    6ms
    Menin Inhibitors in KMT2A-Rearranged and NPM1-Mutated Acute Leukemia: A Scoping Review of Safety and Efficacy. (PubMed, Crit Rev Oncol Hematol)
    Menin inhibitors demonstrate promising clinical activity in molecularly defined leukemias, with Revumenib establishing proof-of-concept for this therapeutic approach. However, challenges remain, including resistance development, optimal timing of therapy initiation, and determination of effective combination strategies. Larger randomized trials with extended follow-up are needed to establish long-term efficacy and safety profiles. The rapid clinical development of multiple agents in this class suggests an expanding role for Menin inhibitors in leukemia treatment paradigms.
    Review • Journal
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • MEN1 (Menin 1)
    |
    NPM1 mutation • KMT2A rearrangement
    |
    Revuforj (revumenib) • Komzifti (ziftomenib) • icovamenib (BMF-219) • bleximenib (JNJ-6617) • emilumenib succinate (DS-1594) • enzomenib (DSP-5336)
    10ms
    COVALENT-101: Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL (clinicaltrials.gov)
    P1, N=55, Active, not recruiting, Biomea Fusion Inc. | Recruiting --> Active, not recruiting | N=177 --> 55
    Enrollment closed • Enrollment change
    |
    icovamenib (BMF-219)
    10ms
    COVALENT-102: Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer (clinicaltrials.gov)
    P1, N=13, Terminated, Biomea Fusion Inc. | N=90 --> 13 | Trial completion date: Oct 2026 --> Jan 2025 | Recruiting --> Terminated | Trial primary completion date: Jun 2025 --> Jan 2025; Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    icovamenib (BMF-219)
    1year
    Complete remission of NUP98 fusion-positive acute myeloid leukemia with the covalent menin inhibitor BMF-219, icovamenib. (PubMed, Haematologica)
    Not available.
    Journal
    |
    NUP98 (Nucleoporin 98 And 96 Precursor 2)
    |
    icovamenib (BMF-219)
    1year
    COVALENT-111: Study of BMF-219 in Healthy Adult Subjects and in Adult Subjects With Type 2 Diabetes Mellitus (T2D) (clinicaltrials.gov)
    P1/2, N=414, Active, not recruiting, Biomea Fusion Inc. | Suspended --> Active, not recruiting | Trial primary completion date: Jul 2024 --> Nov 2024
    Enrollment closed • Trial primary completion date
    |
    icovamenib (BMF-219)
    1year
    BF-MNN-112: Phase 2 Trial of BMF-219 in Participants with Type 1 Diabetes Mellitus (clinicaltrials.gov)
    P2, N=190, Active, not recruiting, Biomea Fusion Inc. | Suspended --> Active, not recruiting
    Enrollment closed
    |
    icovamenib (BMF-219)