MRD validated as a surrogate endpoint for survival in AML

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Published: 17 Dec 2025
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Dr Jesse Tettero - The Hourigan Lab, Washington, D.C., USA

Dr Jesse Tettero speaks to ecancer about a large pooled HARMONY Alliance analysis evaluating measurable residual disease (MRD) as a surrogate endpoint in acute myeloid leukaemia (AML).

The study shows that MRD status after induction therapy is a strong predictor of overall survival across multiple randomised AML trials, regardless of whether MRD was assessed by flow cytometry or qPCR for NPM1.

He explains that MRD demonstrated robust individual-level surrogacy and that, at the trial level, treatment effects on MRD strongly correlated with survival outcomes in non-transplanted patients.

Dr Tettero reports that these findings support the use of MRD - particularly flow cytometry–based MRD - as a regulatory endpoint to enable accelerated drug approval in AML.