Inqovi (decitabine/cedazuridine) / Otsuka 
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 1 Disease   53 Trials   53 Trials   581 News 


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  • ||||||||||  Review, Journal:  Management of Patients with Lower-Risk Myelodysplastic Neoplasms (MDS). (Pubmed Central) -  Aug 1, 2023   
    Several newer agents are being evaluated in phase 3 clinical trials for this group of patients, such as imetelstat and oral azacitidine. This review provides a summary of the classification systems, the prognostic scores and clinical management of patients with lower risk MDS.
  • ||||||||||  Review, Journal:  Oral therapy for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: a revolution in progress. (Pubmed Central) -  Jul 20, 2023   
    The approvals of oral HMAs such as cedazuridine-decitabine (C-DEC) and oral azacitidine (CC-486) have kindled the hope that myeloid malignancies may soon be treated with total oral therapy...Oral HMAs have the potential to be a convenient and efficacy-equivalent treatment option for patients with HR-MDS or AML and improve their quality of life by reducing clinic visits for medication administration. Total-oral therapy combinations, largely including an oral HMA 'backbone,' are in the early phases of clinical development, and it is our hope that well-designed trials employing these agents may soon allow the identification of optimal regimens that deliver effective disease-directed therapy with good tolerability.
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Trial completion:  Ascertain: Study of ASTX727 vs IV Decitabine in MDS, CMML, and AML (clinicaltrials.gov) -  May 31, 2023   
    P3,  N=200, Completed, 
    Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2023 --> Dec 2023 Active, not recruiting --> Completed
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Inqovi (decitabine/cedazuridine) / Otsuka
    PHASE 1/2 STUDY OF ORAL DECITABINE/CEDAZURIDINE IN COMBINATION WITH VENETOCLAX IN TREATMENT-NA (Harmony 2) -  May 12, 2023 - Abstract #EHA2023EHA_2335;    
    P1/2
    Pharmacokinetic, Oral, Peripheral T-cell lymphoma The combination of ASTX727 plus venetoclax is a promising, fully oral combination that is well-tolerated and demonstrates a high response rate in higher-risk MDS decitabine, Myelodysplastic syndrome, Venetoclax, Oral
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    AN ORAL COMBINATION THERAPY OF OR-2100 AND VENETOCLAX IN ACUTE MYELOID LEUKEMIA (Poster area) -  May 12, 2023 - Abstract #EHA2023EHA_1897;    
    OR21 enhanced ROS accumulation with attenuated mitophagy response, leading to increased anti-leukemia effects. OR21 plus Ven is a promising oral combination therapy for AML.
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    PATIENTS (Poster area) -  May 12, 2023 - Abstract #EHA2023EHA_994;    
    Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy. Oral, Hypomethylating agents, Myelodysplastic syndrome, Quality of life
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
    IPSS-M PERFORMANCE IN PATIENTS WITH MYELODYSPLASTIC SYNDROME AT THE TIME OF HYPOMETHYLATING AGENT FAILURE (Poster area) -  May 12, 2023 - Abstract #EHA2023EHA_992;    
    Despite the inclusion of molecular variables and patient stratification, the risk of death may be too high to be adequately captured.Figure 1. Kaplan-Meier survival function for overall survival of patients with HMA failure by IPSS-M categories with p-value for log-rank test.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
    Trial completion date, Trial primary completion date, Combination therapy:  Venetoclax in Combination with Decitabine and Cedazuridine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) -  May 6, 2023   
    P2,  N=20, Recruiting, 
    Kaplan-Meier survival function for overall survival of patients with HMA failure by IPSS-M categories with p-value for log-rank test. Trial completion date: May 2023 --> May 2025 | Trial primary completion date: May 2023 --> May 2025
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Therapeutic Targets in RAS-Mediated Proliferative CMML (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_138;    
    This study evaluated the perspectives of MDS patients receiving oral decitabine and cedazuridine (DEC-C), an alternative to IV/SC HMAs...Among patients who had previously received IV/SC HMAs (n=91), most agreed that DEC-C interfered less with daily life (91%) and had experienced improvement in quality-of-life (85%) compared with previous treatment; 91% reported that DEC-C reduced the number of times they needed to travel to a healthcare facility. Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy.
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    PATIENTS (Auditorium; Virtual) -  Apr 25, 2023 - Abstract #MDS2023MDS_132;    
    Among patients who had previously received IV/SC HMAs (n=91), most agreed that DEC-C interfered less with daily life (91%) and had experienced improvement in quality-of-life (85%) compared with previous treatment; 91% reported that DEC-C reduced the number of times they needed to travel to a healthcare facility . Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy.
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Trial primary completion date, Combination therapy:  Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (clinicaltrials.gov) -  Apr 14, 2023   
    P1/2,  N=124, Active, not recruiting, 
    Conclusions Survey results suggest very little/no impact on regular daily activities and improved quality-of-life with oral DEC-C relative to IV/SC HMAs, highlighting the potential for DEC-C to reduce the treatment burden associated with parenteral HMA therapy. Trial primary completion date: Feb 2023 --> Jul 2024