Commentary

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Dr Landgren on the Utility of MRD as an End Point in Multiple Myeloma Trials

C. Ola Landgren, MD, PhD, discusses the utility of minimal residual disease as an end point in clinical trials for the treatment of multiple myeloma.

C. Ola Landgren, MD, PhD, professor, medicine, Department of Medicine, chief, Division of Myeloma, Department of Medicine, co-leader, Translational and Clinical Oncology Program, Paul J. DiMare Endowed Chair in Immunotherapy, director, Sylvester Myeloma Institute, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Universtiy of Miami Health System, discusses the utility of minimal residual disease (MRD) as an end point in clinical trials evaluating treatments for patients with multiple myeloma.

In April 2024, the FDA’s Oncologic Drugs Advisory Committee voted that available data support the use of MRD as an end point for accelerated approval of new treatments for patients with multiple myeloma, marking an advance in addressing unmet needs within this patient population, Landgren begins. There is a strong demand for an early clinical trial end point that is reasonably likely to predict long-term clinical benefit of agents in patients with multiple myeloma, as there is not yet a cure for this disease, Landgren says. This need prompted Landgren and colleagues to develop a meta-analysis that was designed based on FDA guidance for considering MRD as a clinical end point and a potential basis for accelerated approval, he explains.

Having an early end point that is likely to predict clinical benefit could revolutionize drug development, he expands. Instead of enrolling patients in a clinical trial for 2 years and waiting an additional 10 years for data maturation, a large trial could enroll patients for 2 years, check MRD status after 1 year, and obtain results much faster, Landgren says. If the trial is successful, the drug could be reviewed and approved swiftly, allowing it to reach patients much sooner, he elucidates.

This approach could reduce the wait time for certain agents from 12 years to just 3 years for newly diagnosed patients, expediting access to effective drugs, Landgren continues. In multiple myeloma, where the clinical unmet need is significant and curative treatments are still unavailable, using MRD as an end point presents an opportunity to develop potentially curative therapies, Landgren emphasizes. This shift is crucial for providing patients with faster access to life-saving medications, he concludes.

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