PS1023 MUTANT IDH1 INHIBITOR IVOSIDENIB (AG‐120) IN COMBINATION WITH AZACITIDINE FOR NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA
DiNardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Döhner H, Martinelli G, Patel P, Raffoux E, Tan P, Zeidan A, de Botton S, Kantarjian H, Stone R, Lam D, Wang X, Gong J, Kapsalis S, Hickman D, Zhang V, Winkler T, Wu B, Vyas P. PS1023 MUTANT IDH1 INHIBITOR IVOSIDENIB (AG‐120) IN COMBINATION WITH AZACITIDINE FOR NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA. HemaSphere 2019, 3: 460-461. DOI: 10.1097/01.hs9.0000562388.60660.bc.Peer-Reviewed Original ResearchAcute myeloid leukemiaOverall response rateMorphologic leukemia-free stateComplete remissionAdverse eventsFebrile neutropeniaCR rateMyeloid leukemiaMutant IDH1Isocitrate dehydrogenase 1Double-blind placebo-controlled studyGrade 3/4 adverse eventsRefractory acute myeloid leukemiaBone marrow mononuclear cellsCR/CRhGrade adverse eventsIDH differentiation syndromeIDH1 inhibitor ivosidenibMedian response durationPartial hematologic recoveryPhase 1b studyAbsolute neutrophil countPlacebo-controlled studyTreatment of adultsMarrow mononuclear cellsMutant IDH1 inhibitor ivosidenib (IVO; AG-120) in combination with azacitidine (AZA) for newly diagnosed acute myeloid leukemia (ND AML).
Dinardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Martinelli G, Patel P, Raffoux E, Tan P, Zeidan A, de Botton S, Kantarjian H, Stone R, Lam D, Gong J, Zhang V, Winkler T, Wu B, Vyas P. Mutant IDH1 inhibitor ivosidenib (IVO; AG-120) in combination with azacitidine (AZA) for newly diagnosed acute myeloid leukemia (ND AML). Journal Of Clinical Oncology 2019, 37: 7011-7011. DOI: 10.1200/jco.2019.37.15_suppl.7011.Peer-Reviewed Original ResearchAdverse eventsECG QTFebrile neutropeniaDouble-blind placebo-controlled studyGrade 3/4 adverse eventsBone marrow mononuclear cellsCR/CRhGrade adverse eventsIDH differentiation syndromeIDH1 inhibitor ivosidenibMedian response durationNon-intensive therapyPartial hematologic recoveryPhase 1b studyPlacebo-controlled studyAcute myeloid leukemiaMarrow mononuclear cellsAZA monotherapyD1-7Differentiation syndromeData cutoffHematologic recoveryMedian durationMedian timeSafety profile