Ivosidenib (3) – Tibsovo®

• Clinical trials
  • For the benefit assessment of ivosidenib in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukaemia (AML) who harbour an IDH1 R132 mutation, and who are not suitable for standard induction chemotherapy, the pharmaceutical manufacturer has submitted data from the AGILE trial.
  • The AGILE trial is a randomised, multicentre, controlled Phase IIIstudy, in which ivosidenib in combination with azacitidine was compared with placebo in combination with azacitidine in adult patients with newly diagnosed AML harbouring an IDH1 R132 mutation who are unsuitable for standard induction chemotherapy.
  • The Viale-A trial is a double-blind, randomised, controlled, multicentre Phase III trial comparing the combination therapy of venetoclax and azacitidine with placebo plus azacitidine.

Adults with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not suitable for standard induction chemotherapy

• The additional benefit is not proven.
• The AGILE trial does not allow for a direct comparison with the appropriate comparator therapy and is therefore not suitable for assessing additional benefit.
• The indirect comparisons presented are, on the whole, deemed unsuitable for drawing conclusions regarding additional benefit.
• Consequently, there are no suitable data available overall to enable an assessment of the additional benefit.

Courtesy translation only, please refer to the German original.