^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    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:
    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)
    8d
    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)
    9d
    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)
    20d
    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
    28d
    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)
    1m
    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)
    1m
    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)
    2ms
    Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=126, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • PML (Promyelocytic Leukemia)
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    2ms
    Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (clinicaltrials.gov)
    P2, N=93, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Venclexta (venetoclax) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    ASTX660-03: A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Taiho Oncology, Inc. | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2026 --> Mar 2026
    Phase classification • Trial completion date
    |
    Inqovi (decitabine/cedazuridine) • tolinapant (ASTX660)
    2ms
    DECISIVO: A study to evaluate the safety and efficacy of oral decitabine plus ivosidenib in newly diagnosed adult patients with acute myeloid leukemia older than 60 years and/or inelegible for standard induction chemotherapy (2025-523238-17-00)
    P1/2, N=50, Not yet recruiting, Fundacion PETHEMA
    New P1/2 trial
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 R132
    |
    decitabine • Tibsovo (ivosidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms (clinicaltrials.gov)
    P2, N=27, Recruiting, University of Washington | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine • Inqovi (decitabine/cedazuridine) • Vonjo (pacritinib)