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Important Safety Information

Prescribing Information

AML Study Design

ASCERTAIN-V: A Phase 2 AML clinical trial1

Designed to evaluate the only all-oral regimen for patients with newly diagnosed AML1-3

INQOVI is an oral hypomethylating agent (HMA) therapy approved in combination with venetoclax for patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy.2

ASCERTAIN-V (ASTX727-07; NCT04657081) was a single-arm, open-label, Phase 2 clinical trial that evaluated INQOVI + venetoclax in patients with newly diagnosed AML.1,2 Phase 2 Part A (N=58) assessed efficacy, pharmacokinetics, and safety. The pivotal portion, Phase 2 Part B (N=101), assessed efficacy as a primary objective, and efficacy, pharmacokinetics, and safety as secondary objectives.1-3

Eligibility criteria2

  • Confirmed newly diagnosed AML
  • Ineligible for intensive induction chemotherapy
    • Adults who were 75 years or older, or
    • Adults who had comorbidities that precluded the use of intensive induction chemotherapy based on at least 1 of the following criteria:
      • Baseline ECOG performance status (PS) 2 or 3
      • Severe cardiac disorder or pulmonary comorbidity disorder
      • Moderate hepatic impairment
      • CLcr ≥30 mL/min to <45 mL /min
      • Other comorbidities
Alternate Text INQOVI

Once daily on Days 1 to 5 of each 28-day cycle (35-mg decitabine/100-mg cedazuridine)

Alternate Text
Alternate Text Venetoclax
  • Once daily using a ramp-up schedule on Days 1 to 3 of Cycle 1 (100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3)
  • Once daily on Days 4 to 28 of Cycle 1 (400 mg)
  • Once daily on Days 1 to 28 of subsequent 28-day cycles (400 mg)

*Treatment continued until disease progression or unacceptable toxicity occurred.2

Key endpoints evaluated in the ASCERTAIN-V Phase 2 trial1-3

ENDPOINTS PHASE 2 PART B (N=101)
PRIMARY ENDPOINT Efficacy: Complete remission (CR)
SECONDARY ENDPOINTS Efficacy:
  • CR + CR with partial hematologic recovery (CRh)
  • Time to response
  • Duration of CR (DoCR)
  PHASE 2 PART A (N=58) PHASE 2 PART B (N=101)
SECONDARY ENDPOINTS
  • Pharmacokinetics compatibility of venetoclax on INQOVI exposure
  • Safety

Patient demographics and disease characteristics at baseline2

BASELINE PATIENT CHARACTERISTIC PHASE 2 PART B
(N=101)
AGE (YEARS)
Median (range) 78 (63-88)
SEX (%)
Male 61
Female 40
RACE (%)
White 81
Black or African American 3
Asian 7
Other, not reported, or unknown 10
ECOG PERFORMANCE SCORE (%)
0-1 79
2 18
3 3
AML DISEASE HISTORY (%)
De novo AML 37
Secondary AML 63
MUTATION ANALYSIS DETECTED (%)
TP53 17
IDH1 or IDH2 18
FLT-3 12
NPM1 13
BASELINE COMORBIDITIES (%)
Severe cardiac disease 17
Moderate hepatic impairment 5
Creatinine clearance ≥30 or <45 mL/min 18
RISK CLASSIFICATIONa (n [%])
Favorable 32 (32)
Intermediate 34 (34)
Adverse 30 (30)
Unknown 5 (5)

The clinical cutoff date for the ongoing Phase 2 Part B of the clinical study was September 30, 2024.1

aDefined using 2017 European LeukemiaNet (ELN) genetic risk classification.2

AML efficacy

INQOVI + venetoclax delivered meaningful response and consistent exposure1,2

Explore AML efficacy

AML safety

INQOVI showed a demonstrated safety profile in the Phase 2 clinical trial.1,2

View AML safety

References: 1. Data on file. Taiho Oncology Inc., Princeton, NJ. 2. INQOVI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2026. 3. Pharmacokinetics, safety, and efficacy of ASTX727 in combination with venetoclax in acute myeloid leukemia. ClinicalTrials.gov identifier: NCT04657081. Updated December 8, 2025. Accessed January 20, 2026. https://clinicaltrials.gov/study/NCT04657081