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Drugmakers Come Together Hoping to Formalize MRD as Surrogate Endpoint in AML Trials

NEW YORK – The MPAACT Consortium has launched an initiative to make measurable residual disease (MRD) an established surrogate endpoint for overall survival in acute myeloid leukemia (AML) trials, Janssen said on Thursday.  

MPAACT, which stands for “Measurable residual disease Partnership and Alliance in Acute myeloid leukemia Clinical Treatment,” was established in 2018 as a research alliance between Janssen, Novartis, Amgen, AbbVie, Kronos Bio, Roche subsidiary Genentech, and Bristol Myers Squibb subsidiary Celgene.  

In partnership with academics researching AML, the drugmakers plan to share data from clinical trials they are conducting and show that MRD closely correlates with patients' overall survival. Recognizing that overall survival data readouts can take many years, the consortium members hope to establish MRD as a surrogate endpoint they can use in future AML studies to predict, in a shorter timeframe, whether a drug is likely to extend a patient's life.  

MRD, which reflects the number of cancer cells remaining after patients undergo therapy, has been associated with survival in the past, but there are varying thresholds of undetectable MRD. "The evidence to support the clinical validity of MRD as a biomarker varies across hematologic cancer types and patient populations," the US Food and Drug Administration said in 2020 in a guidance on using MRD to develop treatments for hematologic malignancies. The agency also noted in that document that "MRD assessments can vary among laboratories and technologies, which can cause discrepant results." 

Within MPAACT, the Mayo Clinic Statistics and Data Management Center will perform a meta-analysis of the clinical trial data to evaluate MRD's association with overall survival. Consortium members also want to validate MRD tests that rely on next-generation sequencing and flow cytometry to ensure consistent, high-quality testing across AML trials.  

To achieve these goals, the members will bring together experts within joint advisory boards and at other scientific venues.