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Combination of Ivosidenib and Azacitidine Approved by FDA for IDH1-Mutated AML

By: Lauren Velentzas
Posted: Friday, May 27, 2022

On May 25, the U.S. Food and Drug Administration (FDA) approved the IDH1 inhibitor ivosidenib (Tivsovo) in combination with azacitidine for the treatment of patients aged 75 or older with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) or those who have comorbidities that preclude the use of intensive induction chemotherapy. This application had been granted Priority Review and Breakthrough Therapy designations.

Approval was based on the randomized, multicenter, double-blind, placebo-controlled AG120-C-009 trial. It included 146 newly diagnosed patients with IDH1-mutated AML who were ineligible for intensive chemotherapy: approximately half received ivosidenib plus azaciditine, and the other half received placebo plus azacitidine.

Event-free survival events occurred in 65% of patients given the combination therapy and 84% of those given placebo plus azacitidine (hazard ratio [HR] = 0.35; 95% confidence interval [CI] = 0.17–0.72, P = .0038). Median overall survival was 24.0 months (95% CI = 11.3–34.1 months) in the ivosidenib-plus-azacitidine arm and 7.9 months (95% CI = 4.1–11.3 months) in the placebo-plus-azacitidine arm (HR = 0.44; 95% CI = 0.27–0.73; P = .0010). The complete remission rate was 47% (95% CI = 35%–59%) with ivosidenib plus azacitidine and 15% (95% CI = 8%–25%) with placebo plus azacitidine. The median duration of complete remission was not estimable with ivosidenib plus azacitidine and 11.2 months with the placebo plus azacitidine.

The most common adverse reactions to the combination treatment were nausea, vomiting, electrocardiogram QT prolonged, insomnia, differentiation syndrome, leukocytosis, hematoma, hypertension, arthralgia, dyspnea, and headache (≥ 10%).


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