The phase 3 crossover trial was designed to assess systemic decitabine exposure, demethylation activity, and safety between IV decitabine and INQOVI. The trial allowed for intrapatient comparison in the first 2 randomized treatment cycles, then assessment of the long-term efficacy and safety of INQOVI as a single arm.1,2
Phase 3, open-label, randomized, 2-cycle,
2-sequence, crossover trial design in treatment-experienced or -naive patients with MDS, including CMML (International Prognostic Scoring System [IPSS] Intermediate-1, -2, or high-risk).1
After taking INQOVI, 20% (27/133) of patients went on to receive stem cell transplantation.1
aOne cycle only, per the exclusion criteria.
bDefined as documentation of ≥2 units of transfusion within 56 days of the first day of study treatment.
ECOG=Eastern Cooperative Oncology Group; RBC=red blood cell.
Orally administered INQOVI demonstrated equivalent
systemic exposure to IV-administered decitabine.
Ratio is the geometric mean of the 5-day cumulative decitabine AUC between INQOVI
and IV-administered decitabine when administered once daily for 5 consecutive days
of patients achieved a complete response
(95% CI: 15, 29)
Median Time to CR
Median Duration of CR*
*From start of CR until relapse or death.
AUC=area under the curve; CI=confidence interval.
of patients treated with INQOVI who were initially transfusion dependent achieved posttreatment RBC and platelet transfusion independence (30/57)†
of patients who initially were both RBC and platelet transfusion independent remained transfusion independent (48/76)†
†During any consecutive 56-day postbaseline period.
Safety profile similar to IV decitabine with no unexpected adverse reactions reported in the first 2 cycles1
cPlease see full Prescribing Information for complete list of adverse eventoccurring during all cycles.
dIncludes multiple adverse reaction terms.
eIncludes adverse reactions that occurred during all cycles, including durintreatment with 1 cycle of intravenous decitabine.
fIncludes any lab abnormalities that worsened by ≥1 grades. Grades 3 to 4 include any lab abnormalities that worsened to grade 3 or grade 4.
gThe 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 [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2022 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