Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation assessment report (EMEA/H/C/005823, 2023)
Otsuka Holdings Co., Ltd. · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
Otsuka Pharmaceutical Netherlands B.V. sought a Type II variation for Inaqovi (decitabine/cedazuridine) to extend its indication for newly diagnosed acute myeloid leukaemia (AML) patients unsuitable for standard induction chemotherapy, in combination with venetoclax. The application relied on interim results from study ASTX727-07, an open-label pharmacokinetic, safety, and efficacy study. This report details the scientific assessment, including non-clinical and clinical aspects, focusing on pharmacokinetic analyses and drug-drug interactions. The clinical pharmacology, efficacy, and trial design of Study ASTX727-07, encompassing Phase 1, Phase 2 Part A, and the pivotal Phase 2 Part B, were evaluated, showing complete response rates, duration of response, and overall survival. The assessment concluded that the oral regimen's efficacy and safety were comparable to IV decitabine plus venetoclax, supported by PK bridging and Phase 2 data (46.5% CR rate). The CHMP recommended approval, citing a positive benefit-risk balance and significant clinical benefit.
Key findings — cited to the page
| Treatment-related Grade ≥3 AEs | 68.3% | ASTX727-07 · p.86 |
| Study type for new indication | single-arm, open-label pharmacokinetic, safety, and efficacy study | ASTX727-07 · p.6 |
| first subject enrolled | 09 February 2021 | ASTX727-07 Phase 1 · p.43 |
| number of sites | 50 | ASTX727-07 · North America, Europe · p.43 |
| New therapeutic indication | Extension of indication to include treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy for INAQOVI in combination with venetoclax | Inaqovi · p.6 |
| trial phase | Phase 1/2 | ASTX727-07 · p.36 |
| first subject enrolled | 10 April 2023 | ASTX727-07 Phase 2 Part B · p.43 |
| first subject enrolled | 04 November 2021 | ASTX727-07 Phase 2 Part A · p.43 |
| data cutoff date | 17 July 2024 | ASTX727-07 Phase 1 · p.43 |
| data cutoff date | 30 Sep 2024 | ASTX727-07 Phase 2 Part A and Part B · p.43 |
| Application type | Type II variation | Inaqovi · p.6 |
| Market protection extension request | 1-year year | · p.6 |
Source: Otsuka Holdings Co., Ltd. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →