Patients aged ≥60 years with late-stage, mutant-IDH2 acute myeloid leukemia (AML) relapsed/refractory (R/R) to 2 or 3 prior AML-directed therapies
Enasidenib (n=158) vs. CCR (azacitidine, intermediate-dose cytarabine, low-dose cytarabine, or supportive care) (n=161)
Efficacy
mOS: 6.5 vs. 6.2 mos, HR:0.86, p=0.230
mEFS: 4.9 vs. 2.6 mos , HR:0.68, p=0.008
ORR: 40.5% vs. 9.9%
Safety
Any grade AEs: nausea (22% vs. 16%), Bilirubin increased (19.7% vs. 0.7%), thrombocytopenia (15.3 % vs. 10.6%), neutropenia (8.3% vs. 12.1%)
Grade 5 AEs: 1 pts in the enasidenib arm (hepatic failure during cycle 2) and 5 pts in the CCR arm (acute myocardial infarction [during follow-up], cerebral hemorrhage [on day 14], febrile neutropenia [on day 37], pneumonia [on day 13], and sepsis [on day 5]).
