^
    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:
    3d
    Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1/2, N=3, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Drug company withdrew support.
    Trial termination
    |
    Inqovi (decitabine/cedazuridine) • eltanexor (KPT-8602)
    10d
    Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1/2, N=209, Recruiting, Washington University School of Medicine | N=126 --> 209
    Enrollment change
    |
    Inqovi (decitabine/cedazuridine)
    11d
    LANTana: Lutathera and ASTX727 in Neuroendocrine Tumours (clinicaltrials.gov)
    P1, N=27, Recruiting, Imperial College London | Trial completion date: Dec 2025 --> Feb 2029 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine) • Lutathera (lutetium Lu 177 dotatate)
    24d
    NCI-2021-00893: Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=84, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Venclexta (venetoclax) • Tibsovo (ivosidenib) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    24d
    NCI-2021-02246: Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia Patients (clinicaltrials.gov)
    P1/2, N=5, Active, not recruiting, National Cancer Institute (NCI) | N=55 --> 5 | Trial completion date: Oct 2025 --> Nov 2026 | Trial primary completion date: Oct 2025 --> Jun 2025
    Enrollment change • Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • cytarabine • daunorubicin • Inqovi (decitabine/cedazuridine) • Starasid (cytarabine ocfosfate)
    1m
    The conundrum of drug development in higher-risk MDS: Lessons learned from recently failed phase 3 clinical trials. (PubMed, Blood)
    Aside from allogeneic transplantation, the current standard of care approach for higher-risk myelodysplastic syndromes/neoplasms (HR-MDS) remains monotherapy with a hypomethylating agent (HMA) including azacitidine, decitabine, or oral decitabine/cedazuridine...In this review, we discuss lessons learned from the recently reported negative trials of azacitidine in combination with eprenetapopt (APR-246), magrolimab, pevonedistat, sabatolimab, tamibarotene, and venetoclax...Instead, we advocate for using the IWG 2023 response criteria to better capture clinically meaningful benefits in HR-MDS. Lastly, we emphasize the need for the scientific community to access patient-level data and samples from failed phase 3 trials in an efficient and expedited fashion to inform the development of subsequent trials.
    P3 data • Journal
    |
    TP53 (Tumor protein P53)
    |
    Venclexta (venetoclax) • azacitidine • eprenetapopt (APR-246) • pevonedistat (MLN4924) • Inqovi (decitabine/cedazuridine) • magrolimab (ONO-7913) • sabatolimab (MBG453) • Amnolake (tamibarotene)
    1m
    Decitabine-cedazuridine in patients with MDS and TP53 mutations. (PubMed, Blood Adv)
    Median survival was 13.1 months (95% CI: 8.4 - 21.3) for DEC-C vs 8.0 months (95% CI: 5.2 - 13.0) for single agent parenteral HMA (log-rank, p=0.047). In patients with MDS harboring TP53mut, DEC-C may improve overall survival compared to parenteral HMA.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Inqovi (decitabine/cedazuridine)
    2ms
    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 | Suspended --> Active, not recruiting
    Enrollment closed
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)
    2ms
    Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)
    P1/2, N=8, Active, not recruiting, University of Colorado, Denver | Trial completion date: Jul 2026 --> Oct 2026 | Trial primary completion date: Jul 2025 --> Oct 2025
    Trial completion date • Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    3ms
    Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients (clinicaltrials.gov)
    P1, N=13, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | Trial completion date: Jan 2025 --> Sep 2024 | Trial primary completion date: Jan 2025 --> Sep 2024
    Trial completion • Phase classification • Trial completion date • Trial primary completion date • IO biomarker
    |
    Imfinzi (durvalumab) • azacitidine • Imjudo (tremelimumab-actl) • Inqovi (decitabine/cedazuridine)
    3ms
    ASTX727-03: Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS (clinicaltrials.gov)
    P1/2, N=160, Active, not recruiting, Taiho Oncology, Inc. | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine)
    3ms
    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, Not yet recruiting, University of Washington
    New P2 trial
    |
    azacitidine • Inqovi (decitabine/cedazuridine) • Vonjo (pacritinib)