Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

The study needed to test a combination of two drugs, ivosidenib (also called AG-120) and enasidenib (also called AG-221), in patients with a type of blood cancer called acute myeloid leukemia (AML). The study tests the combination of ivosidenib and enasidenib along with the standard treatment for AML. Standard treatment includes: induction therapy (initial treatment) and consolidation therapy (follow-up treatment).

In some cancers like AML, an abnormal (mutated) form of a protein called isocitrate dehydrogenase (IDH) is present in the tumor cells because of changes called mutations. There are two types of IDH proteins in the body: IDH1 and IDH2. When IDH1 or IDH2 is mutated, it makes too much of 2- hydroxyglutarate (2-HG), which is normally present in cells in small amounts. When there is too much 2-HG, it impairs normal cell functioning and may cause the cells to become tumor cells. Ivosidenib blocks the activity of abnormal IDH1 proteins and enasidenib blocks the activity of abnormal IDH2 proteins. These drugs may reduce the levels of 2-HG in cancer cells back to normal.

The main goal of the study is to see how safe and well-tolerated the study drugs are when used with other approved treatments in patients with AML and IDH1 or IDH2 mutations.