Clinical Data Show Patient, Cost Benefits of MRD Testing in Multiple Myeloma

New real-world data presented at the American Society of Hematology (ASH) 62nd Annual Meeting demonstrated the clinical utility of Adaptive Biotechnologies’ clonoSEQ next-generation sequencing (NGS) assay to detect minimal residual disease (MRD) in multiple myeloma patients.¹ The impact of MRD assessment was also shown in patients with chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and mantle cell lymphoma (MCL) in various abstracts at the virtual meeting.

Currently, clonoSEQ is the only FDA-cleared test to assess MRD in lymphoid malignancies. MRD, the presence of a small number of cancer cells in a patient’s body during or after treatment, can inform physician decisions on a patient’s course of treatment and allow earlier intervention in patients whose disease is likely to recur. Testing for MRD is gaining traction in clinical trials, but evidence is more limited in clinical applications.

One University of California San Francisco (UCSF) abstract presented data from a 3-center, retrospective study of 373 multiple myeloma patients who had at least one MRD assessment.² Decisions to change treatment were separated into 3 groups: stop or reduce treatment after MRD negative results (n + 24), increase intensity of treatment after MRD positive results (n = 20), or start a new treatment line after MRD positive results (n = 13). Of the patients who underwent testing, 16% had a resulting change in treatment.

Of the 58 patients whose treatments changed after MRD testing, 33 were MRD positive and 25 were negative at the time of decision. In that group, 33 patients either remained MRD negative achieved MRD negativity eventually. Patients who had changes made to their treatments after MRD testing had a median PFS of 97 months vs 75 months in patients whose therapy remained the same (P = 0.006).

“We are encouraged by these real-world data and the impact MRD testing can have on the way we manage patients who have had great but not perfect responses to therapy, and the way we can make earlier decisions,” Jeffrey Wolf, MD, clinical professor in the Department of Medicine at UCSF and director of the myeloma program at UCSF Helen Diller Family Comprehensive Cancer Center, said in a statement. “These results support the integration of MRD assessment as a standard of care in the management of multiple myeloma patients. MRD assessment allows physicians and patients alike to have more confidence in their treatment decisions.”

Another abstract projected the cost-effectiveness of MRD testing in multiple myeloma patients.³ The study evaluated potential cost savings based on a model that would allow patients with continual MRD negativity, defined as <10^-5 across two assessments at least 12 months apart, to discontinue indefinite maintenance treatment.

Based on the estimated potential maintenance therapy cost-savings or no longer requiring active treatment for relapsed/refractory disease, utilizing clonoSEQ for MRD testing could result in a lifetime savings of $916,000 per patient each year and $181,000,000 for an annual cohort of patients at Emory University’s Winship Cancer Institute, where the study model was based. Avoiding treatment-related adverse events with the more precise approach slightly improved patient outcomes in the model (0.009 quality-adjusted life years).

“The data presented at ASH this year reflect the growing evidence supporting clonoSEQ’s ability to provide meaningful benefit for patients with blood cancers in a variety of clinical settings,” Lance Baldo, MD, chief medical officer of Adaptive Biotechnologies, said in a statement. “It is increasingly clear that MRD testing with clonoSEQ, utilizing our immune medicine platform, is playing an important role in treatment decision-making which can have a dramatic impact not only on patients, but could also enable cost savings for the healthcare system overall.”

References

1. Adaptive Biotechnologies Announces New Clinical Data Demonstrating Impact of clonoSEQ® Assay on Patients with Blood Cancers at the 62nd ASH Annual Meeting. News release. Adaptive Biotechnologies Corporation;December 6, 2020. Accessed December 7, 2020. https://investors.adaptivebiotech.com/news-releases/news-release-details/adaptive-biotechnologies-announces-new-clinical-data

2. Lopez JM, Fernández RA, Wong SW, et al. Making Clinical Decisions to Change Therapy Using Measurable Residual Disease Improves the Outcome in Multiple Myeloma. Presented at American Society of Hematology 62nd Annual Meeting; December 5-8, 2020. Abstract 2237.

3. Carlson JJ, Zimmermann M, Demaree A, Hewitt T, Eckert B, Nooka A. Cost-Effectiveness of Implementing Clonoseq NGS-MRD Testing Using the Emory MRD Decision Protocol in Multiple Myeloma. Presented at American Society of Hematology 62nd Annual Meeting; December 5-8, 2020. Abstract 3426.