Cancer Treatment Today

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend MRD testing as a Category 2A recommendation for multiple myeloma patients after each treatment stage (e.g., induction, high-dose therapy/ASCT, consolidation, maintenance) at times of suspected complete response. Next-generation sequencing (NGS) is specifically included in these guidelines among the recommended tools for MRD assessment. NCCN also recommends it for ALL. However,a athough regulatorily cleared, there is no propctive evidence that it helps in management of lympmas.c A recent study by Wlazer et la, conlcudedes: “elapse after CAR T-cell therapy remains a significant clinical challenge. New predictors are indicated to determine which responding patients after CAR-T cell therapy are more likely to relapse. Utilizing the commercially available Adaptive clonoSEQ® assay, early MRD assessment was not predictive of long-term clinical outcomes in DLBCL and FL. MRD positive patients maintained durable remission and converted to MRD negativity, while early MRD negative patients continued to relapse. In contrast, MRD negativity post-CAR-T therapy did appear to predict durable clinical remission in MCL patients. Newer assays, including cell-free technologies, may be more informative for non-MCL histologies.”

U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

Ching T, Duncan ME, Newman-Eerkes T, McWhorter MME, Tracy JM, Steen MS, Brown RP, Venkatasubbarao S, Akers NK, Vignali M, Moorhead ME, Watson D, Emerson RO, Mann TP, Cimler BM, Swatkowski PL, Kirsch IR, Sang C, Robins HS, Howie B, Sherwood A. Analytical evaluation of the clonoSEQ Assay for establishing measurable (minimal) residual disease in acute lymphoblastic leukemia, chronic lymphocytic leukemia, and multiple myeloma. BMC Cancer. 2020 Jun 30;20(1):612. doi: 10.1186/s12885-020-07077-9. PMID: 32605647; PMCID: PMC7325652.