BMS' Idhifa fails in combination trial
US pharma major Bristol Myers Squibb (NYSE: BMY) has announced a setback for its Phase III IDHENTIFY trial in relapsed or refractory acute myeloid leukemia (R/R AML).
Idhifa (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with R/R AML with an isocitrate dehydrogenase-2 (IDH2) mutation.
Noah Berkowitz, senior vice president, global clinical development, Hematology, BMS, said: “While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in Idhifa’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study.
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