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Integrating menin inhibitors into the treatment landscape of AML: Future directions
Featured:
Joshua Zeidner
Test your knowledge! Take our quick quiz before and after you read this article to find out if you improved your knowledge. Results help us to improve content and continually provide open-access education.
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For which population is revumenib currently approved by the FDA?
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The AML Hub was pleased to speak with Joshua Zeidner, UNC Lineberger Comprehensive Cancer Center, North Carolina, US. We asked for his thoughts on the topic “Integrating menin inhibitors into the treatment landscape of AML: Future directions”.
Zeidner provides an overview of the latest clinical trial data presented at the European Hematology Association 2025 Congress (EHA 2025), on menin inhibitors for the treatment of NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) AML.
Integrating menin inhibitors into the treatment landscape of AML: Future directions
Key learnings
Revumenib is currently the only FDA-approved agent specifically for patients with KMT2Ar relapsed/refractory (R/R) AML; the incorporation of menin inhibitors into frontline treatment approaches is an area of high interest and was discussed in several presentations at the congress.
The updated final analysis of the phase Ib Beat AML study revealed revumenib added to an azacitidine + venetoclax backbone in newly diagnosed (ND), older, unfit patients with NPM1m or KMT2Ar AML had high clinical activity, with a composite overall response rate of 88%.1
Given the positive phase I Beat AML data, the revumenib + azacitidine + venetoclax regimen will be investigated in comparison with placebo, in the upcoming pivotal randomized EVOLVE-2 phase III study in the same population.1
An updated analysis of a study of bleximenib in the treatment of R/R and ND AML, demonstrated high response rates in combination with azacitidine + venetoclax.2
Bleximenib was initiated on Day 4 of Cycle 1 (after venetoclax + azacitidine administration on Day 1), which differs from the Beat AML study approach where revumenib was given concomitantly with azacitidine + venetoclax.1,2
Emerging data from studies of menin inhibitors plus intensive chemotherapy in a frontline setting, in newly diagnosed patients with AML, were also presented.
In a study of ziftomenib in combination with 7+3 intensive chemotherapy for the treatment of younger, fit patients with NPM1m or KMT2Ar AML, high response rates of over 90% were also observed. The maximum tolerated dose was 600 mg ziftomenib + 7+3 daily, and a reasonable safety profile was demonstrated.3
Future directions for the ziftomenib + 7+3 intensive chemotherapy regimen include a pivotal phase III study of this regimen compared with placebo in younger, fit patients with NPM1m or KMT2Ar AML.3
Several additional phase II studies of menin inhibition in younger fit, and older unfit, patients with AML are currently being planned.
This educational resource is independently supported by Johnson & Johnson. 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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