Co-developed by Japan-based Otsuka and British Astex, Inaqovi has been cleared by EC as monotherapy in AML patients who are ineligible for a standard induction chemotherapy
A cell image of Acute Myeloid Leukaemia. (Credit: Paulo Henrique Orlandi Mourao from Wikimedia Commons)
Otsuka Pharmaceutical and Astex Pharmaceuticals have received approval from the European Commission (EC) for Inaqovi (oral decitabine and cedazuridine) to treat adult patients with newly diagnosed acute myeloid leukaemia (AML).
Inaqovi is an oral fixed-dose combination of 35mg decitabine, an approved hypomethylating agent, and 100mg cedazuridine, a cytidine deaminase inhibitor.
Co-developed by Japan-based Otsuka and British Astex, Inaqovi has been cleared by EC as monotherapy in AML patients who are ineligible for standard induction chemotherapy.
The approval was backed by the findings from the Phase 3 ASCERTAIN clinical trial that enrolled 89 AML patients who were randomised 1:1 to receive Inaqovi orally in Cycle 1 and decitabine intravenously in Cycle 2 or the reverse sequence.
The late-stage trial assessed the pharmacokinetic exposure equivalence of the fixed-dose combination against intravenous (IV) decitabine in AML patients.
As per the results, the trial met its primary endpoint. The oral combination showed pharmacokinetic exposure equivalence to a standard five-day regimen of IV decitabine in a two-cycle, cross-over study design.
The secondary findings revealed a Median Overall Survival of 7.9 months and a Complete Response rate of 21.8% at 7.95 months median follow-up.
Additionally, the safety profile of the oral therapy was comparable to intravenous decitabine.
Around 14% of patients permanently discontinued the treatment, with pneumonia being the most common reason for discontinuation.
The European Economic Area (EEA), which consists of the EU member states as well as Iceland, Liechtenstein, and Norway, is covered by the EC approval.
Inaqovi is said to be the first and only oral hypomethylating medication authorised in the EEA for this patient population.
Furthermore, the European Medicines Agency (EMA) is investigating Inaqovi’s use for AML treatment in the paediatric population.
Recently, the Japanese firm partnered with American drugmaker Shape Therapeutics to develop intravitreally delivered adeno-associated virus (AAV) therapeutics for ocular diseases.