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    DRUG:

    Inqovi (decitabine/cedazuridine)

    i
    Other names: ASTX727, ASTX 727, oral C-DEC, DEC-C
    Company:
    Otsuka
    Drug class:
    DNMT inhibitor, Cytidine deaminase inhibitor
    Related drugs:
    22h
    Venetoclax in Combination With Decitabine and Cedazuridine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    3d
    HyPeR: Combination Study of Guadecitabine/ASTX727 and Pembrolizumab (clinicaltrials.gov)
    P1, N=60, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=34 --> 60
    Enrollment closed • Enrollment change
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Inqovi (decitabine/cedazuridine) • guadecitabine (SGI-110)
    8d
    A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=47, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Oct 2026 --> Jul 2026
    Enrollment open • Trial initiation date
    |
    CD4 (CD4 Molecule)
    |
    Inqovi (decitabine/cedazuridine) • Neupogen (filgrastim)
    16d
    Targeting the IL-8 axis in high-risk myelodysplastic syndromes: a clinical experience with antibody blockade combined with decitabine/cedazuridine. (PubMed, Leuk Lymphoma)
    Clinical and laboratory findings are presented from a 64-year-old female with myelodysplastic syndrome and increased blasts-2 (MDS-IB2) from Phase I/II trial evaluating the anti-IL8 antibody, BMS-986253, in combination with oral decitabine/cedazuridine (NCT05148234). Optical genome mapping identified ETS-related gene, ERG, somatic duplication with post-treatment decreased variant allele frequency. Post-treatment molecular changes with clinical disease stability, suggest IL-8 pathway inhibition biological activity after even short duration.
    Journal
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD33 (CD33 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • ERG (ETS Transcription Factor ERG)
    |
    Inqovi (decitabine/cedazuridine) • BMS-986253
    18d
    Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, OHSU Knight Cancer Institute | Trial completion date: Jun 2026 --> Dec 2026
    Trial completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)
    27d
    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)
    1m
    A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancer. (PubMed, Cancer)
    ASTX727 plus talazoparib produces significant myelosuppression without other adverse events. Modest methylation changes in PBMCs were detected. There were no objective responses, but some heavily pretreated patients had stable disease for >4 months despite the attenuated doses.
    P1 data • Journal • BRCA Biomarker • PARP Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset) • DNMT1 (DNA methyltransferase 1)
    |
    HER-2 negative • BRCA mutation
    |
    Talzenna (talazoparib) • Inqovi (decitabine/cedazuridine)
    1m
    Serial Determinations of Molecular Aberrations in Patients with Acute Myeloid Leukemia During Treatment with Oral Decitabine/Cedazuridine. (PubMed, Cancers (Basel))
    Disease-modifying activity with decreases in mutated clones is rare. Although the exact mechanism behind our findings remains undetermined, they are in line with the proposed effects of HMA on epigenetics in leukemia cells.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1)
    |
    IDH2 mutation • NPM1 mutation • RAS mutation
    |
    Inqovi (decitabine/cedazuridine)
    1m
    DECISIVO: Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, PETHEMA Foundation
    New P2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    cytarabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine) • hydroxyurea
    2ms
    NIBIT-ML-1: A randomized, run-in, phase II study of nivolumab combined with ipilimumab and oral decitabine/cedazuridine (ASTX727) or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 (2024-518891-29-00)
    P1/2, N=148, Recruiting, Fondazione NIBIT Onlus | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • BRAF mutation • ALK translocation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Inqovi (decitabine/cedazuridine)
    2ms
    ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (clinicaltrials.gov)
    P1/2, N=31, Not yet recruiting, University of Wisconsin, Madison
    New P1/2 trial
    |
    Inqovi (decitabine/cedazuridine) • Zynyz (retifanlimab-dlwr)
    2ms
    ETCTN: Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (clinicaltrials.gov)
    P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Jan 2027
    Trial completion date
    |
    Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)