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The oral IDH1 inhibitor ivosidenib put about a third of patients with relapsed or refractory IDH1-mutated acute myeloid leukaemia into remission, with some clearing the mutation altogether, leading to its approval.
Phase 1 dose-escalation and expansion study of 258 patients with IDH1-mutated advanced haematological cancers, including 179 with relapsed or refractory AML treated at 500 mg daily.
In the primary efficacy population the rate of complete remission or complete remission with partial haematological recovery was 30.4 percent, median duration of response 8.2 months, and 21 percent of responders had no detectable IDH1 mutation. Differentiation syndrome occurred in about one in ten.
IDH1 testing at diagnosis and relapse now directs patients to a targeted oral drug; ivosidenib went on to be combined with azacitidine in newly diagnosed disease (AGILE).
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib, New England Journal of Medicine.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib.
Shares IDH1- and IDH2-mutated acute myeloid leukaemia, Ivosidenib.