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What is INQOVI?
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Prescribing Inqovi
The phase 3 crossover trial was designed to assess systemic decitabine exposure, demethylation activity, and safety between IV decitabine and INQOVI® (decitabine and cedazuridine) tablets. The trial allowed for intrapatient comparison in the first 2 randomized treatment cycles, and then assessment of the long-term efficacy and safety of INQOVI as a single arm.1,2
Open-label, randomized, 2-cycle, 2-sequence, crossover clinical trial in treatment-experienced or -naive patients with MDS, including CMML (International Prognostic Scoring System [IPSS] Intermediate-1, -2, or high-risk).1
aOne cycle only, per the exclusion criteria.
bDefined as documentation of ≥2 units of transfusion with 56 days of the first day of study treatment.
ECOG=Eastern Cooperative Oncology Group; RBC=red blood cell.
Orally administered INQOVI® (decitabine and cedazuridine) tablets demonstrated equivalent
systemic exposure to IV-administered decitabine.
99%
ratio of oral to IV 5-day decitabine AUC
(90% Cl: 93, 106)
21%
of patients achieved a complete response
(CR, 95% CI: 15, 29)
7.5 months
median duration of CR*
(range: 1.6-17.5)
*From start of CR until relapse or death.
4.3 months
median time to CR
(range: 2.1-15.2)
AUC=area under the curve; CI=confidence interval.
53%
of the patients treated with INQOVI who were initially transfusion dependent achieved posttreatment RBC and platelet transfusion independence (30/57)†
†During any consecutive 56-day postbaseline period.
63%
of patients who initially were both RBC and platelet transfusion independent remained transfusion independent (48/76)†
aPlease see full Prescribing Information for complete list of adverse events occurring during all cycles.
bIncludes multiple adverse reaction terms.
cIncludes adverse reactions that occurred during all cycles, including during treatment with 1 cycle of intravenous decitabine.
aIncludes any lab abnormalities that worsened by ≥1 grades. Grades 3 to 4 include any lab abnormalities that worsened to grade 3 or grade 4.
bThe denominator used to calculate the rate varied from 103 to 107 for INQOVI cycle 1, from 102 to 106 for the IV decitabine cycle, and from 203 to 208 for INQOVI (all cycles) based on the number of patients with a baseline value and ≥1 posttreatment value.
Please see full Prescribing Information for chemistry lab safety parameters.
References: 1. INQOVI. Prescribing information. Taiho Oncology Inc; 2020. 2. Garcia-Manero G, Griffiths EA, Steensma DP, et al. Oral cedazuridine/decitabine: a phase 2, pharmacokinetic/pharmacodynamic, randomized, crossover study in MDS and CMML. Blood. doi:10.1182/blood.2019004143.
What is INQOVI?
Prescribing Inqovi