Inaqovi(decitabine + cedazuridine)
Oncology· 87 cited findings· 1 source document
Company: Otsuka Holdings Co., Ltd.
What the regulatory reviews say
Inaqovi (decitabine + cedazuridine) is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. The drug received a Type II variation application for an extension of indication to include its use in combination with venetoclax. Inaqovi monotherapy was approved in the EU for AML in 2023.
In clinical trials, Inaqovi demonstrated a complete response (CR) rate by investigator of 46.5% (95% CI: 36.5% - 56.7%). The median time to CR was 2.37 months, and the median overall survival (OS) was 15.5 months. The median duration of response (DoR) for CR was 17.5 months. The CR + CRi rate was 63.4%, and the CR + CRh rate was 51.5%.
Safety findings included haematologic toxicity in 76.7% of patients, infections in 61.4%, and gastrointestinal disorders in 70.9%. Treatment-related Grade ≥3 adverse events occurred in 68.3% of patients, and treatment-related serious adverse events in 31.2%. Discontinuation due to treatment-related adverse events was 3.2%, and fatal treatment-related adverse events occurred in 3.7% of patients.
Key figures — cited to the source page
| CR rate by investigator | 46.5 | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.54 |
| CR rate by investigator (95% CI lower bound) | 36.5 | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.54 |
| CR rate by investigator (95% CI upper bound) | 56.7 | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.54 |
| median OS | 15.5 | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.55 |
| Haematologic toxicity | 76.7% | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.85 |
| Infections | 61.4% | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.85 |
| Treatment-related Grade ≥3 AEs | 68.3% | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.86 |
| Fatal treatment-related AE | 3.7% | Otsuka Holdings Co., Ltd. — Inaqovi EMA EPAR variation asses, p.86 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.