Measurable Residual Disease (MRD) as a Surrogate Efficacy-Response Biomarker in AML

In acute myeloid leukemia (AML) many patients experience relapse, despite the achievement of morphological complete remission; therefore, conventional morphologic criteria are currently considered inadequate for assessing the quality of the response after treatment. Quantification of measurable residual disease (MRD) has been established as a strong prognostic marker in AML and patients that test MRD negative have lower relapse rates and better survival than those who test positive. Different techniques, varying in their sensitivity and applicability to patients, are available for the measurement of MRD and their use as a guide for selecting the most optimal post-remission therapy is an area of active investigation. Although still controversial, MRD prognostic value promises to support drug development serving as a surrogate biomarker, potentially useful for accelerating the regulatory approval of new agents. In this review, we will critically examine the methods used to detect MRD and its potential role as a study endpoint.

Automated summary

In acute myeloid leukemia (AML), many patients experience relapse despite achieving complete remission. Traditional morphologic criteria are inadequate for assessing treatment response. Quantification of measurable residual disease (MRD) is a strong prognostic marker in AML, with MRD-negative patients having lower relapse rates and better survival. Different techniques for detecting MRD are available, and their use in guiding post-remission therapy is being actively investigated. Despite controversy, the prognostic value of MRD shows promise in supporting drug development and potentially expediting regulatory approval of new agents.