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New Indication: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML

New Indication: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML
Study:
  • Phase III, randomized, open-label study
  • 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]).

Blood (2023) 141 (2): 156–167.

Botton S et al. ¨Enasidenib vs conventional care in older patients with late-stage mutant-IDH2 relapsed/refractory AML: a randomized phase 3 trial¨

http://doi.org/blood.2021014901

Reviewed by Elvin CHALABİYEV, MD on FEB 24, 2023

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