Ivosidenib regimen extends EFS in IDH1-mutated AML
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The addition of ivosidenib tablets to azacitidine prolonged EFS among patients with previously untreated IDH1-mutated acute myeloid leukemia, according to topline data released by the agent’s manufacturer.
Ivosidenib (Tibsovo, Servier) is an IDH1 inhibitor. The agent is approved in the United States for two specific groups of adults with IDH1-mutated AML: those with relapsed or refractory disease, or those with newly diagnosed disease who are aged 75 years or older or who have comorbidities that preclude them from undergoing intensive induction chemotherapy.
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The randomized phase 3 AGILE trial included patients with newly diagnosed AML who are not eligible for intensive chemotherapy.
Researchers assigned patients to azacitidine plus ivosidenib tablets or placebo.
The trial achieved its primary endpoint, as ivosidenib-treated patients achieved significantly longer EFS. The trial also met its key secondary endpoints, which included complete remission rate, OS, objective response rate, and a composite of complete remission or complete remission with partial hematologic recovery.
The independent data monitoring committee recommended enrollment be stopped based on the clinically important difference between treatment groups.
The safety profile of ivosidenib plus azacitidine appeared consistent with previously published data.
Complete results from the trial will be submitted for presentation at a medical meeting.
“The results of AGILE represent a major breakthrough and will be welcome news for patients dealing with previously untreated IDH1-mutated acute myeloid leukemia,” Claude Bertrand, executive vice president for research and development with Servier Group, said in a company-issued press release. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.”
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