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


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  • ||||||||||  Review, Journal, IO biomarker:  Current status and research directions in acute myeloid leukemia. (Pubmed Central) -  Sep 21, 2024   
    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.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Inqovi (decitabine/cedazuridine) / Otsuka
    Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=100, Recruiting, 
    Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025 N=40 --> 100 | Trial completion date: Oct 2024 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2026
  • ||||||||||  BMS-986253 / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
    Effects of In Vivo IL-8 Axis Blockade on Myeloid Derived Suppressor Cells (MDSC) in a Patient With High-Risk MDS and Excess Blasts (LEVEL 3, HALL B3) -  Aug 30, 2024 - Abstract #SOHO2024SOHO_605;    
    P1/2
    Case Report: A 64-year-old female patient with treatment-refractory high-risk MDS and increased blasts (15-20%) was treated with combination oral decitabine-cedazuridine and the anti-IL-8 antibody in a phase 1 clinical protocol (NCT05148234)...CD45+CXCR1+ cells decreased by ~39%, whereas CD45+CXCR2+ increased. Collectively, the data suggest that blocking IL-8, even at low doses, can decrease the egress of MDSCs, which could have therapeutic implications in MDS patients and should be further investigated in clinical trials.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Aug 21, 2024   
    P2,  N=39, Active, not recruiting, 
    Collectively, the data suggest that blocking IL-8, even at low doses, can decrease the egress of MDSCs, which could have therapeutic implications in MDS patients and should be further investigated in clinical trials. Trial completion date: Jun 2024 --> Oct 2024
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Journal:  Patients' perspectives on oral decitabine/cedazuridine for the treatment of myelodysplastic syndromes/neoplasms. (Pubmed Central) -  Aug 2, 2024   
    Among patients who had previously received IV/SC HMAs (n?=?91), most agreed that oral DEC-C interfered less with daily life (91%) and had experienced improvement in QOL (85%) compared with previous treatment; 91% reported that oral DEC-C reduced the number of times they needed to travel to a healthcare facility. Survey results suggest very little/no impact on regular daily activities and improved QOL with oral DEC-C relative to IV/SC HMAs, highlighting the potential for oral DEC-C to reduce the treatment burden associated with parenteral HMA therapy.
  • ||||||||||  Opdivo (nivolumab) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
    Biomarker, Enrollment change, Trial withdrawal, Metastases:  ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) -  Jul 3, 2024   
    P1,  N=0, Withdrawn, 
    N=65 --> 0 | Trial completion date: Aug 2026 --> Jul 2024 | Not yet recruiting --> Withdrawn N=15 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  Opdivo (nivolumab) / BMS, Inqovi (decitabine/cedazuridine) / Otsuka
    Trial primary completion date, Combination therapy, Checkpoint inhibition, IO biomarker, Checkpoint block, Metastases:  Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal Melanoma (clinicaltrials.gov) -  Jun 25, 2024   
    P1/2,  N=30, Recruiting, 
    N=15 --> 0 | Not yet recruiting --> Withdrawn Trial primary completion date: Jul 2024 --> Jul 2025
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Enrollment closed, Enrollment change:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  May 20, 2024   
    P2,  N=39, Active, not recruiting, 
    Not yet recruiting --> Recruiting | N=750 --> 2000 Recruiting --> Active, not recruiting | N=90 --> 39
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Review, Journal:  Advances in the management of higher-risk myelodysplastic syndromes: future prospects. (Pubmed Central) -  May 7, 2024   
    Moreover, in a disease of high genomic complexity such as HR-MDS, therapy targeting specific genomic abnormalities is of interest. This review will examine the biological underpinnings of HR-MDS, its therapeutic landscape in the frontline and relapsed settings, as well as the impact of hematopoietic stem cell transplantation, the only known curative intervention for this disease.
  • ||||||||||  sabatolimab (MBG453) / Novartis
    Trial completion date, Trial primary completion date:  STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS (clinicaltrials.gov) -  Apr 23, 2024   
    P2,  N=90, Recruiting, 
    Prior studies reported that the immune infiltrate of CS at progression is immunosuppressive; higher immune infiltrate is correlated with worse outcomes (4). Trial completion date: Mar 2025 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Sep 2023
  • ||||||||||  Inqovi (decitabine/cedazuridine) / Otsuka
    Trial completion date, Trial primary completion date:  ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas (clinicaltrials.gov) -  Mar 29, 2024   
    P1,  N=18, Recruiting, 
    Our findings should be confirmed in larger multicentric studies. Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2022 --> May 2024
  • ||||||||||  Ayvakit (avapritinib) / Blueprint Medicines
    New P1 trial, Combination therapy:  Avapritinib With Decitabine in Patients With SM-AHN (clinicaltrials.gov) -  Mar 25, 2024   
    P1,  N=34, Recruiting, 
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), guadecitabine (SGI-110) / Otsuka, Inqovi (decitabine/cedazuridine) / Otsuka
    Enrollment open, Combination therapy:  HyPeR: Combination Study of Guadecitabine/ASTX727 and Pembrolizumab (clinicaltrials.gov) -  Mar 21, 2024   
    P1,  N=34, Recruiting, 
    Better education of multidisciplinary teams on the factors affecting HMA treatment selection may help to improve treatment outcomes in patients with MDS or AML. Active, not recruiting --> Recruiting
  • ||||||||||  Nucala (mepolizumab) / GSK, Fasenra (benralizumab) / AstraZeneca, Inqovi (decitabine/cedazuridine) / Otsuka
    A Case of Pulmonary Eosinophilia Refractory to Stem Cell Transplant (San Diego Convention Center, Area H (Hall H, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_5645;    
    Mepolizumab 300mg every 4 weeks was later added by his outside pulmonologist for possible eosinophilic granulomatosis with polyangiitis...A bone marrow biopsy showed evidence of myelodysplastic syndrome, for which he received one cycle of decitabine plus cedazuridine prior to undergoing SCT...Intravenous glucocorticoids were started followed by Benralizumab 30mg subcutaneously...2018. 00049