Key clinical point: Combination therapy with enasidenib and azacitidine (Ena-AZA) was well tolerated and had a better response rate than azacitidine alone (AZA) in patients with newly diagnosed (ND) mutant- IDH2 acute myeloid leukemia (AML) and ineligible for intensive chemotherapy (IC).
Major finding: The overall response rate was significantly higher in patients receiving Ena-AZA vs. AZA (74% vs. 36%; odds ratio 4.9; P = .0003). The most frequent grade 3 or 4 events in the Ena-AZA vs. AZA groups were thrombocytopenia (37% vs. 19%) and neutropenia (37% vs. 25%).
Study details: Findings are from the phase 2 AG221-AML-005 study including 101 adult patients with ND mutant- IDH2 AML who were ineligible for IC. They were randomly assigned to Ena-AZA (n = 68) or AZA (n = 33).
Disclosures: This study was funded by Celgene, a wholly owned subsidiary of Bristol Myers Squibb (BMS). MG Frattini, P Martin-Regueira, F Lersch, J Gong, and M Hasan reported employment and equity ownership in BMS/Celgene. Other authors reported receiving grants, personal fees, royalties, nonfinancial support, research funding, and honoraria from various sources, including BMS/Celgene.
Source: DiNardo CD et al. Lancet Oncol. 2021;22(11):P1597-P1608 (Oct 18). Doi: 10.1016/S1470-2045(21)00494-0.