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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:
    2d
    Testing the Combination of Targeted Radiotherapy With Anti-Cancer Drugs, Venetoclax and ASTX-727, to Improve Outcomes for Adults With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=53, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine) • Actimab-A (lintuzumab-Ac225)
    4d
    ASCERTAIN-V: Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1/2, N=101, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    4d
    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 primary completion date: Oct 2025 --> Aug 2026
    Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    7d
    Venetoclax/FluBu2 RIC transplant followed by all-oral venetoclax/decitabine maintenance for poor risk MDS/AML. (PubMed, Blood Adv)
    To improve the tolerability of post-transplant maintenance and outcomes despite poor risk disease genetics, we conducted a phase 1 study of venetoclax/FluBu2 RIC transplantation with tacrolimus/methotrexate GVHD prophylaxis followed by all-oral venetoclax/decitabine-cedazuridine (ven/dec-c) maintenance in poor-risk MDS/AML patients (N=30). PROs assessed in first 6-months of maintenance were stable except for emotional function, which improved (P=0.008). Trial is registered at clinicaltrials.gov/NCT03613532.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • methotrexate • Inqovi (decitabine/cedazuridine)
    10d
    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)
    17d
    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)
    18d
    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)
    1m
    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)
    1m
    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)