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Decitabine and cedazuridine

(Inqovi®)

Inqovi®

Drug updated on 12/11/2024

Dosage FormTablet (oral; decitabine/cedazuridine 35 mg/100 mg)
Drug ClassNucleoside metabolic inhibitors and cytidine deaminase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Oral decitabine-cedazuridine demonstrated pharmacokinetic equivalence to intravenous decitabine, with he area under the curve (AUC) of oral therapy reaching 98.93% (90% confidence interval (CI) 92.66-105.60) of that for intravenous administration, indicating comparable decitabine exposure over 5 days.
  • The study included patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and no significant differences in effectiveness outcomes were reported across various subgroups or population types.
  • Oral decitabine-cedazuridine showed similar effectiveness to intravenous decitabine, establishing it as a viable alternative for the targeted patient populations.
  • The most frequent Grade 3 or worse adverse events with oral decitabine-cedazuridine were thrombocytopenia (61%), neutropenia (57%), and anemia (50%), similar to the intravenous decitabine group.
  • Serious adverse events (SAEs) were more common with oral decitabine-cedazuridine (31%) compared to intravenous decitabine (18%), and treatment-related deaths were slightly higher with intravenous decitabine (3 deaths) versus oral therapy (2 deaths).
  • The study population included individuals aged 18 or older with myelodysplastic syndromes or chronic myelomonocytic leukemia, with an Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of at least 3 months. No specific differences in effectiveness or safety were reported based on gender or race, though the population was predominantly male (65%) and White (91%).