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Lancet Oncol: Efficacy and safety of IDH2 inhibitor Enasidenib combined with azacitidine in the treatment of IDH2 mutant acute myeloid leukemia

 Last Update: 2021-11-03
 Source: Internet
 Author: User

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Enasidenib is an oral inhibitor of mutant isocitrate dehydrogenase-2 (IDH2) protein

This is an open-label Phase 1b/2 trial conducted in 43 clinical centers in 12 countries, recruiting patients with acute myeloid leukemia who have an ECOG performance status of 0-2 at the age of 18 years

From June 3, 2016 to August 2, 2018, 322 patients were screened , of which 107 patients with acute myeloid leukemia with IDH2 mutations were included in the study

Screening

Event-free survival rate of the two groups

In the phase 2 study, 101 patients were randomly assigned to the Enasidenib+azacitidine group (n=68) or the azacitidine alone group (n=33)

Fifty (74%) patients in the combination group achieved remission, while only 12 (36%) patients in the azacitidine group achieved remission.

Side effects

The most common grade 3/4 side effects are thrombocytopenia (combination group vs single agent group: 37% vs 19%), neutropenia (37% vs 25%), and anemia (19% vs 22%) And febrile neutropenia (16% vs 16%)

In summary, compared with azacitidine monotherapy, Enasidenib combined with azacitidine is well tolerated in newly diagnosed IDH2 mutant acute myeloid leukemia patients, and the overall remission rate is significantly improved, suggesting that The program can improve the clinical prognosis of such patients

Compared with azacitidine monotherapy, Enasidenib combined with azacitidine is well tolerated in newly diagnosed IDH2 mutant acute myeloid leukemia patients, and the overall remission rate is significantly improved, suggesting that this program can improve this type of The clinical prognosis of patients is compared with azacitidine monotherapy.

Original source:

Courtney D DiNardo, et al.

Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial

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