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Long-term efficacy and safety results from the phase III AGILE trial

By Eloise Aston

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Oct 15, 2025

Learning objective: After reading this article, learners will be able to summarize the key long-term efficacy and safety results from the AGILE trial, including the effect of MRD status on survival outcomes.


Do you know... Which of the following statements is true about patients with MRD-negativity who received ivosidenib in the AGILE trial, at a median follow-up of 28.6 months?

At a median follow-up of 28.6 months, patients with newly diagnosed IDH1-mutated acute myeloid leukemia receiving ivosidenib plus azacitidine in the phase III AGILE trial had significantly longer overall survival and faster, more durable hematologic recovery. Ten out of 33 evaluable patients who received ivosidenib converted to measurable residual disease negativity. There was no overall relationship between measurable residual disease negativity and survival outcomes. However, patients with <1% variant allele frequency who were measurable residual disease negative had significantly longer overall and event-free survival and longer duration of response than those with ≥1% variant allele frequency. Ivosidenib maintained its previously reported safety profile. 

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This educational resource was independently supported by Servier. All content was developed by SES in collaboration with an expert steering committee; funders were allowed no influence on the content of this resource.

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