Decitabin / Cedazuridin (1) – Inaqovi®

• Clinical trials
  • ASTX727-02 is a completed Phase III trial, divided into an open-label, actively controlled phase and a single-arm phase.

Adults with newly diagnosed acute myeloid leukaemia (AML) who are not eligible for standard induction chemotherapy

• The additional benefit is not proven.
• In summary, there are no suitable data available to enable an assessment of additional benefit; therefore, additional benefit of decitabine/cedazuridine is not proven for the treatment of adults with newly diagnosed AML who are not eligible for standard induction chemotherapy.
• Overall assessment
  • The results of the registration trial ASTX727-02 are available for the assessment of the additional benefit of decitabine/cedazuridine. As the duration of treatment was too short for both decitabine/cedazuridine and the comparator therapy decitabine in the controlled phase of the trial, there is no adequate comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.