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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:
    4d
    Maintenance Therapy in Acute Myeloid Leukemia: Current Perspectives and Future Directions. (PubMed, Curr Oncol)
    Oral azacitidine (CC-486) demonstrated overall survival benefit in older patients in first complete remission who were not transplant candidates, establishing a standard of care in this population. In FLT3-mutated AML, post-transplant maintenance with sorafenib and gilteritinib reduces relapse risk, with emerging evidence supporting MRD as a predictive biomarker for benefit. Other targeted agents and immunotherapies have shown promising early-phase results, although confirmatory data are limited. Ongoing phase III studies will clarify optimal patient selection, treatment duration, and integration with transplantation, aiming to transform post-remission management from passive surveillance to precision-based relapse prevention.
    Review • Journal • IO biomarker
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    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
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    sorafenib • Xospata (gilteritinib) • Onureg (azacitidine oral)
    4d
    ORAZ-351: Oral Azacitidine Maintenance Post-CPX 351 (clinicaltrials.gov)
    P=N/A, N=100, Completed, Centre Hospitalier Universitaire de Nice | Recruiting --> Completed | Trial completion date: Jan 2025 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • Onureg (azacitidine oral)
    17d
    Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma (clinicaltrials.gov)
    P3, N=93, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    PD-1 (Programmed cell death 1) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    gemcitabine • romidepsin • Onureg (azacitidine oral)
    26d
    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 2026 --> Apr 2027 | Trial primary completion date: May 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Opdivo (nivolumab) • Onureg (azacitidine oral)
    2ms
    FLO_CC-486-: Pilot Study of CC 486 (Oral Azacitidine) Plus BSC as Maintenance After sc Azacitidine in Elderly HR-IPSS-R MDS Patients (clinicaltrials.gov)
    P2, N=11, Completed, University of Florence | Active, not recruiting --> Completed
    Trial completion
    |
    Onureg (azacitidine oral)
    2ms
    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, Terminated, Bristol-Myers Squibb | Suspended --> Terminated; Insufficient Enrollment
    Trial termination
    |
    Onureg (azacitidine oral)
    2ms
    An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Bristol-Myers Squibb | Trial completion date: Mar 2026 --> Oct 2026
    Trial completion date
    |
    Onureg (azacitidine oral)
    2ms
    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, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • CD4 (CD4 Molecule)
    |
    doxorubicin hydrochloride • cyclophosphamide • vincristine • Onureg (azacitidine oral) • Truxima (rituximab-abbs) • Rituxan Hycela (rituximab/hyaluronidase) • Mabtas (rituximab biosimilar)
    2ms
    Oracle: Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL (clinicaltrials.gov)
    P3, N=86, Completed, The Lymphoma Academic Research Organisation | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2025
    Trial completion • Trial completion date
    |
    PD-1 (Programmed cell death 1) • BCL6 (B-cell CLL/lymphoma 6) • CXCL13 (Chemokine (C-X-C motif) ligand 13) • ICOS (Inducible T Cell Costimulator) • MME (Membrane Metalloendopeptidase)
    |
    gemcitabine • bendamustine • romidepsin • Onureg (azacitidine oral)
    2ms
    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)
    3ms
    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)
    3ms
    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)