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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:
    4d
    Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting | N=18 --> 8 | Trial completion date: Jan 2025 --> Mar 2026
    Enrollment closed • Enrollment change • Trial completion date
    |
    TP53 (Tumor protein P53) • RB1 (RB Transcriptional Corepressor 1)
    |
    Xtandi (enzalutamide capsule) • Inqovi (decitabine/cedazuridine)
    20d
    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=55, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Oct 2025 | Trial primary completion date: Aug 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • cytarabine • daunorubicin • Inqovi (decitabine/cedazuridine) • Starasid (cytarabine ocfosfate)
    25d
    Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=36 --> 0 | Initiation date: Jul 2024 --> Jan 2025 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial initiation date • Trial withdrawal
    |
    Inqovi (decitabine/cedazuridine) • beroterkib anhydrous (ASTX029)
    2ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    2ms
    ASTX727-10: A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS) (clinicaltrials.gov)
    P2, N=2, Terminated, Astex Pharmaceuticals, Inc. | N=100 --> 2
    Enrollment change
    |
    Inqovi (decitabine/cedazuridine) • magrolimab (ONO-7913)
    2ms
    Oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukaemia: A randomised, crossover, registration, pharmacokinetics study. (PubMed, Br J Haematol)
    Next-generation sequencing was performed to identify molecular abnormalities that impact OS and TP53 mutations were associated with a poor outcome. These findings support the use of oral DEC-C in patients with AML.
    PK/PD data • Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Inqovi (decitabine/cedazuridine)
    2ms
    Current status and research directions in acute myeloid leukemia. (PubMed, Blood Cancer J)
    Since 2017, twelve agents have been approved for the treatment of AML subsets: the BCL2 inhibitor venetoclax; the CD33 antibody drug conjugate gemtuzumab ozogamicin; three FLT3 inhibitors (midostaurin, gilteritinib, quizartinib); three IDH inhibitors (ivosidenib and olutasidenib targeting IDH1 mutations; enasidenib targeting IDH2 mutations); two oral hypomethylating agents (oral poorly absorbable azacitidine; fully absorbable decitabine-cedazuridine [latter approved as an alternative to parenteral hypomethylating agents in myelodysplastic syndrome and chronic myelomonocytic leukemia but commonly used in AML]); and CPX-351 (encapsulated liposomal 5:1 molar ratio of cytarabine and daunorubicin), and glasdegib (hedgehog inhibitor)...To achieve optimal results in such a rare and heterogeneous entity as AML requires expertise, familiarity with this rare cancer, and the access to, and delivery of disparate therapies under rigorous supportive care conditions. In this review, we update the standard-of-care and investigational therapies and outline promising current and future research directions.
    Review • Journal • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD33 (CD33 Molecule) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    IDH1 mutation • IDH2 mutation
    |
    Venclexta (venetoclax) • Xospata (gilteritinib) • azacitidine • Rydapt (midostaurin) • Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine) • Rezlidhia (olutasidenib) • Daurismo (glasdegib)
    2ms
    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 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Venclexta (venetoclax) • Tibsovo (ivosidenib) • Idhifa (enasidenib) • Inqovi (decitabine/cedazuridine)
    2ms
    Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=100, Recruiting, M.D. Anderson Cancer Center | N=40 --> 100 | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    2ms
    A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE) (clinicaltrials.gov)
    P1/2, N=43, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • Revuforj (revumenib) • Inqovi (decitabine/cedazuridine)
    3ms
    Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov)
    P2, N=70, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Sep 2027 --> Feb 2028
    Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • decitabine • spartalizumab (PDR001) • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    3ms
    ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase (clinicaltrials.gov)
    P2, N=70, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    dasatinib • Inqovi (decitabine/cedazuridine)
    3ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2024 --> Oct 2024
    Trial completion date
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    4ms
    Effect of Food on Blood Levels of ASTX727 (clinicaltrials.gov)
    P1, N=18, Completed, Astex Pharmaceuticals, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    Inqovi (decitabine/cedazuridine)
    4ms
    A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation (clinicaltrials.gov)
    P2, N=0, Withdrawn, M.D. Anderson Cancer Center | N=65 --> 0 | Trial completion date: Aug 2026 --> Jul 2024 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial completion date • Trial withdrawal
    |
    Inqovi (decitabine/cedazuridine)
    4ms
    A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=40, Recruiting, M.D. Anderson Cancer Center | Suspended --> Recruiting | N=58 --> 40
    Enrollment open • Enrollment change • Combination therapy
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    5ms
    ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P1, N=0, Withdrawn, Case Comprehensive Cancer Center | N=15 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Metastases
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    5ms
    Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov)
    P1/2, N=30, Recruiting, University of Colorado, Denver | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial primary completion date • Combination therapy • Checkpoint inhibition • IO biomarker • Checkpoint block • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    5ms
    Decitabine/Cedazuridine and Enzalutamide for the Treatment of Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=18, Recruiting, Roswell Park Cancer Institute | Phase classification: P1b --> P1
    Phase classification • Metastases
    |
    TP53 (Tumor protein P53) • RB1 (RB Transcriptional Corepressor 1)
    |
    Xtandi (enzalutamide capsule) • Inqovi (decitabine/cedazuridine)
    6ms
    A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P3, N=13, Active, not recruiting, Otsuka Australia Pharmaceutical Pty Ltd | Recruiting --> Active, not recruiting | N=42 --> 13 | Trial primary completion date: Apr 2025 --> Jan 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine) • Onureg (azacitidine oral)
    6ms
    A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1, N=58, Suspended, M.D. Anderson Cancer Center | Recruiting --> Suspended
    Trial suspension
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    6ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=39, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=90 --> 39
    Enrollment closed • Enrollment change
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    6ms
    Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P1, N=24, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • paclitaxel • Inqovi (decitabine/cedazuridine)
    6ms
    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=32, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed • Metastases
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)
    6ms
    A dose determining trial to assess the recommended dose of ES-3000 and ASTX727 for patients with Myelodysplasia (ACTRN12621001713886)
    P1/2, N=32, Recruiting, Australasian Leukaemia and Lymphoma Group | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Inqovi (decitabine/cedazuridine)
    7ms
    Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment (clinicaltrials.gov)
    P1, N=18, Recruiting, Astex Pharmaceuticals, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    Inqovi (decitabine/cedazuridine)
    7ms
    Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment (clinicaltrials.gov)
    P1, N=27, Recruiting, Astex Pharmaceuticals, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    Inqovi (decitabine/cedazuridine)
    7ms
    Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab. (clinicaltrials.gov)
    P2, N=70, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2028 --> Feb 2028
    Trial completion date
    |
    Venclexta (venetoclax) • azacitidine • decitabine • spartalizumab (PDR001) • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    7ms
    Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Pamela Munster | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRCA (Breast cancer early onset)
    |
    Lynparza (olaparib) • Inqovi (decitabine/cedazuridine)
    7ms
    STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov)
    P2, N=90, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
    Trial completion date • Trial primary completion date
    |
    azacitidine • decitabine • Inqovi (decitabine/cedazuridine) • sabatolimab (MBG453)
    7ms
    Phase 1 Trial of ASTX727 in Subjects With Lower-risk Myelodysplastic Syndromes (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Otsuka Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jan 2026 | Trial primary completion date: Dec 2023 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    Inqovi (decitabine/cedazuridine)
    7ms
    ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Case Comprehensive Cancer Center
    New P1 trial • Metastases
    |
    Opdivo (nivolumab) • Inqovi (decitabine/cedazuridine)
    7ms
    SOHO State of the Art Updates and Next Questions: An Update on Higher Risk Myelodysplastic Syndromes. (PubMed, Clin Lymphoma Myeloma Leuk)
    There has been import of the IDH1 inhibitor ivosidenib, initially approved for AML; the Bcl-2 inhibitor venetoclax and liposomal daunorubicin/cytarabine (CPX-351) are under active investigation as well. Unfortunately, effective treatment of TP53-mutated disease remains elusive, though preliminary evidence suggests improved outcomes with oral decitabine/cedazuridine over parenteral hypomethylating agent monotherapy. Investigational agents with novel mechanisms of action may help expand the repertoire of treatment options for HR-MDS and trials continue to offer a hopeful therapeutic avenue for suitable patients.
    Review • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Inqovi (decitabine/cedazuridine)
    8ms
    Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1/2, N=188, Active, not recruiting, Astex Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    8ms
    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)
    P1/2, N=132, Active, not recruiting, Astex Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Inqovi (decitabine/cedazuridine) • tolinapant (ASTX660)
    8ms
    ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas (clinicaltrials.gov)
    P1, N=18, Recruiting, Massachusetts General Hospital | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2022 --> May 2024
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    IDH2 mutation
    |
    Inqovi (decitabine/cedazuridine)
    8ms
    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 | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Venclexta (venetoclax) • Inqovi (decitabine/cedazuridine)
    8ms
    Avapritinib With Decitabine in Patients With SM-AHN (clinicaltrials.gov)
    P1, N=34, Recruiting, H. Lee Moffitt Cancer Center and Research Institute
    New P1 trial • Combination therapy
    |
    Ayvakit (avapritinib) • Inqovi (decitabine/cedazuridine)
    8ms
    Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=34, Completed, Kathy Miller | Recruiting --> Completed | Trial completion date: Jul 2025 --> Mar 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Talzenna (talazoparib) • Inqovi (decitabine/cedazuridine)
    8ms
    HyPeR: Combination Study of Guadecitabine/ASTX727 and Pembrolizumab (clinicaltrials.gov)
    P1, N=34, Recruiting, Royal Marsden NHS Foundation Trust | Active, not recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Inqovi (decitabine/cedazuridine) • guadecitabine (SGI-110)
    8ms
    Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=12, Recruiting, OHSU Knight Cancer Institute | Trial completion date: Oct 2024 --> Jun 2025 | Trial primary completion date: Apr 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    TP53 (Tumor protein P53) • RUNX1 (RUNX Family Transcription Factor 1) • MAPK1 (Mitogen-activated protein kinase 1) • NTRK (Neurotrophic receptor tyrosine kinase) • MAPK3 (Mitogen-Activated Protein Kinase 3)
    |
    TP53 mutation • NTRK expression
    |
    Rozlytrek (entrectinib) • Inqovi (decitabine/cedazuridine)
    8ms
    A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P3, N=42, Recruiting, Otsuka Australia Pharmaceutical Pty Ltd | Not yet recruiting --> Recruiting | Phase classification: P3b --> P3
    Enrollment open • Phase classification
    |
    Inqovi (decitabine/cedazuridine) • Onureg (azacitidine oral)