An abstract presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition assessed real-world data on patients with multiple myeloma to provide insight into longitudinal testing patterns and rates of sustained minimal residual disease (MRD) negativity.
Minimal residual disease (MRD) testing has been shown to aid in prognostication and is being investigated as a biomarker to inform therapy decisions in multiple myeloma (MM). An abstract presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition provided insight into patterns in MRD testing and sustained MRD negativity in a real-world cohort of MM patients.
In MM, studies have found that MRD negativity correlates with longer progression-free survival and overall survival, the study authors note. The International Myeloma Working Group and National Comprehensive Cancer Network guidelines also include sustained MRD negativity—2 consecutive negative results more than 12 months apart with a threshold of 10-5—as part of the recommended treatment algorithm for symptomatic MM. In clinical trials, MRD negativity is in focus as a possible primary endpoint.
“Standardized, sensitive, and serial MRD assessment is useful to support both routine patient management consistent with guidelines, and clinical studies which incorporate MRD as a primary endpoint,” the authors wrote.
The only MRD testing authorized by the FDA for use in patients with MM using bone marrow is next generation sequencing via a ClonoSEQ assay (manufactured by Adaptive Biotechnologies). The test is standardized, sensitive, and widely available, making it a formidable option for assessing real-world data on testing.
For the study, researchers pulled real-world data from January of 2018 to July of 2021, which included 1561 MM patients at a variety of institutions who had at least 2 MRD tests after a baseline clonality test. The median testing interval for patients with 2 or more tests was 195 days, and 616 patients had 3 or more tests.
Of the patients who had 2 or more tests, 24% (383) had sustained MRD at a threshold of 10-5 for at least 12 months, and 14.7% of patients (231) had sustained negativity at the threshold of 10-6 for at least 12 months.
In the cohort with 3 or more tests, 32.5% (200) sustained negativity at 10-5 throughout the testing period, and 16.6% (102) sustained negativity at the 10-6 threshold. Of patients with a minimum of 3 tests, 12.3% (76) converted from MRD negative to positive at the at 10-5 threshold, and 9.9% (61) at the 10-6 threshold. Thirty-one percent (191) of patients with 3 or more tests converted from positive to negative at the at 10-5 threshold, while 29.4% (181) went from positive to negative at the 10-6 threshold.
“Serial measurement of MRD can facilitate a dynamic assessment of risk for disease progression in patients with MM,” the authors wrote, “and this real-world analysis of MRD clinical samples provides insight into serial testing patterns and sustained MRD-negativity using next-generation sequencing.”
Jiang M, Lee LW, Eckert B, Demaree A, Hewitt T. Longitudinal MRD assessment in real-world multiple myeloma patients using next-generation sequencing (clonoSEQ® assay). Abstract presented at: 63rd American Society of Hematology Annual Meeting; December 11-14, 2021; Atlanta, GA.