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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:
    10d
    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)
    17d
    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)
    18d
    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)
    23d
    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)
    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 | Trial completion date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2026 --> Jun 2026
    Trial completion date • Trial primary completion date • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL15 (Interleukin 15)
    |
    STAT3 mutation
    |
    Onureg (azacitidine oral)
    29d
    Pembrolizumab and epigenetic modification with azacitidine reshapes the tumor microenvironment of platinum-resistant epithelial ovarian cancer: a phase 2 non-randomized clinical trial. (PubMed, Commun Med (Lond))
    Our findings highlight the potential of epigenetic modulators to re-shape the tumor microenvironment of PROC toward a more inflammed phenotype and may point to approaches to augment immunotherapy response.
    Clinical • P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Platinum resistant
    |
    CD8 (cluster of differentiation 8) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    Keytruda (pembrolizumab) • Onureg (azacitidine oral)
    1m
    Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies (clinicaltrials.gov)
    P1, N=26, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Dec 2025
    Trial completion • Trial completion date
    |
    TNFRSF8 positive
    |
    lenalidomide • dexamethasone • Istodax (romidepsin) • 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 | N=32 --> 2 | Active, not recruiting --> Terminated; Insufficient Enrollment
    Enrollment change • Trial termination
    |
    Onureg (azacitidine oral)
    3ms
    Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=36, Active, not recruiting, Groupe Francophone des Myelodysplasies | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • Onureg (azacitidine oral)
    3ms
    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 | N=78 --> 34
    Enrollment change
    |
    Onureg (azacitidine oral)
    3ms
    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)
    4ms
    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)