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    DRUG:

    Onureg (azacitidine oral)

    i
    Other names: CC 486, CC-486, BMS-986345, BMS986345, CC486, BMS 986345
    Company:
    BMS
    Drug class:
    DNMT inhibitor
    Related drugs:
    2d
    A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    lenalidomide • Onureg (azacitidine oral)
    25d
    T-LGLL: Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=11, Active, not recruiting, Jonathan Brammer | Recruiting --> Active, not recruiting | N=27 --> 11
    Enrollment closed • Enrollment change • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
    |
    STAT3 mutation
    |
    Onureg (azacitidine oral)
    30d
    Novel agents for acute myeloid leukemia not yet approved in Japan (PubMed, Rinsho Ketsueki)
    This review focuses on menin inhibitors and covers IDH inhibitors, oral azacitidine, antibody-drug conjugates, bispecific antibodies, radioisotope therapies, and CAR-T cell therapies for AML. Menin inhibitors, which are particularly effective against AML with KMT2A rearrangements or NPM1 mutations, have shown promising results in clinical trials. These novel agents may expand treatment options and improve outcomes for AML patients.
    Review • Journal • IO biomarker
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    NPM1 mutation • KMT2A rearrangement
    |
    Onureg (azacitidine oral)
    3ms
    A051902: Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma (clinicaltrials.gov)
    P2, N=170, Suspended, Alliance for Clinical Trials in Oncology | Recruiting --> Suspended
    Trial suspension
    |
    PD-1 (Programmed cell death 1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    TNFRSF8 expression
    |
    doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Copiktra (duvelisib) • vincristine • prednisone • Onureg (azacitidine oral)
    3ms
    Acute myeloid leukemia: a comprehensive update. (PubMed, Curr Opin Hematol)
    The integration of genomic insights with emerging therapies is transforming AML management. These developments are paving the way toward more personalized care, improved outcomes, and new opportunities for long-term disease control and cure.
    Journal • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    sorafenib • Onureg (azacitidine oral)
    4ms
    Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    Keytruda (pembrolizumab) • Onureg (azacitidine oral)
    5ms
    AMLM22/D4: The International AML Platform Consortium (IAPC) trial – Combining Oral Azacitidine and Dendritic Cell Vaccination Vididencel in maintenance (CADENCE) (ACTRN12624000738527)
    P2, N=140, Recruiting, Australian Leukaemia and Lymphoma Group (ALLG) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    NPM1 (Nucleophosmin 1)
    |
    Onureg (azacitidine oral) • vididencel (DCP-001)
    5ms
    Histamine dihydrochloride and low-dose interleukin-2 in an emerging landscape of relapse prevention in acute myeloid leukemia. (PubMed, Ther Adv Hematol)
    More recent trials have identified efficacious remission maintenance strategies, including (1) midostaurin or quizartinib for patients with FLT3-mutated AML, (2) oral azacitidine for older AML patients, and (3) immunotherapy with histamine dihydrochloride and low-dose interleukin-2 (HDC/IL-2) for younger patients. We discuss clinical efficacy in relation to patient age and anti-leukemic immunity as well as leukemic cell chemosensitivity, chromosomal integrity, and mutational profiles. Finally, we propose a role for HDC/IL-2 within an evolving landscape of strategies to achieve durable remission in a broader population of AML patients.
    Review • Journal • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    midostaurin • Vanflyta (quizartinib) • Onureg (azacitidine oral)
    5ms
    T-LGLL: Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia (clinicaltrials.gov)
    P1/2, N=27, Recruiting, Jonathan Brammer | Trial primary completion date: Aug 2024 --> Jan 2026
    Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • IL15 (Interleukin 15)
    |
    STAT3 mutation
    |
    Onureg (azacitidine oral)
    5ms
    VIALE-M: A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (clinicaltrials.gov)
    P3, N=112, Active, not recruiting, AbbVie | Trial completion date: May 2025 --> Jun 2026
    Trial completion date
    |
    Venclexta (venetoclax) • Onureg (azacitidine oral)
    5ms
    A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Onureg (azacitidine oral)
    6ms
    NCI-2021-13436: CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, City of Hope Medical Center | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Onureg (azacitidine oral)