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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:
    5d
    The new era of AML therapy: current standards and emerging targets. (PubMed, Int J Clin Oncol)
    Key advancements include the integration of FLT3 inhibitors into intensive chemotherapy and the emergence of venetoclax...Innovations such as the liposomal formulation CPX-351 and oral formulations of CC-486 and oral decitabine/cedazuridine have further optimized treatment delivery and improved patient quality of life...Current research is actively exploring next-generation inhibitors, antibody-drug conjugates, and cellular immunotherapies such as BiTEs and CAR-T cells. This review summarizes the recent pharmacological evolution in AML and discusses how these emerging therapies bring us closer to the ultimate goal of achieving a definitive cure.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A)
    |
    TP53 mutation • NPM1 mutation • KMT2A rearrangement • MLL mutation
    |
    Venclexta (venetoclax) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Inqovi (decitabine/cedazuridine) • Onureg (azacitidine oral)
    14d
    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, Completed, AbbVie | Active, not recruiting --> Completed | Trial completion date: Jun 2026 --> Feb 2026
    Trial completion • Trial completion date
    |
    Venclexta (venetoclax) • Onureg (azacitidine oral)
    16d
    Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=24, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Dec 2026 --> Mar 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Onureg (azacitidine oral)
    20d
    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 | Trial completion date: Jun 2026 --> May 2027 | Trial primary completion date: Jun 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    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)
    1m
    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=2, Suspended, Bristol-Myers Squibb | Recruiting --> Suspended
    Trial suspension
    |
    Onureg (azacitidine oral)
    1m
    Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma (clinicaltrials.gov)
    P2/3, N=422, Suspended, National Cancer Institute (NCI) | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Mar 2026 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CD4 (CD4 Molecule)
    |
    Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • vincristine • Onureg (azacitidine oral) • Truxima (rituximab-abbs) • Mabtas (rituximab biosimilar)
    1m
    MIVONU: Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, French Innovative Leukemia Organisation
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib) • Onureg (azacitidine oral)
    1m
    Effectiveness and Safety of ONUREG (Oral Azacitidine) in Chinese Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P=N/A, N=44, Active, not recruiting, Bristol-Myers Squibb
    New trial
    |
    Onureg (azacitidine oral)
    2ms
    ASTREON: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P2/3, N=230, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Jul 2026 --> Jul 2028 | Trial primary completion date: Jan 2026 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    Onureg (azacitidine oral)
    2ms
    Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma (clinicaltrials.gov)
    P2, N=24, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2026 --> Dec 2026 | Trial primary completion date: Feb 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Onureg (azacitidine oral)
    2ms
    FILO-AML-01-MIVONUnA single arm phase II study investigating the efficacy and safety of the addition of ivosidenib to oral azacitidine (Onureg) in patients over 55 with Acute Myeloid Leukemia (AML) and IDH1 mutation, in complete remission after intensive chemotherapy. A study of the French AML Intergroup. (2025-521322-14-00)
    P1/2, N=60, Not yet recruiting, French Innovative Leukemia Organization
    New P1/2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    Tibsovo (ivosidenib) • Onureg (azacitidine oral)
    2ms
    RELION: Characteristics and Outcomes of Acute Myeloid Leukemia (AML) Patients Treated With Oral-Azacitidine Maintenance Therapy in France (clinicaltrials.gov)
    P=N/A, N=112, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Jan 2026 | Trial primary completion date: Oct 2024 --> Jan 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    Onureg (azacitidine oral)