- Treatment adapted studies show the potential for MRD assessment to guide the personalization of blood cancer care
- New data demonstrates MRD assessed from blood in multiple myeloma may be an indicator of early response
Minimal residual disease, also known as measurable residual disease, refers to the residual malignant cells that can be present in the body after treatment at very low levels and can only be identified by highly sensitive tests. clonoSEQ, which is the only FDA-cleared test for MRD assessment in lymphoid malignancies, is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.
“The already-substantial body of evidence supporting clonoSEQ’s prognostic value and clinical actionability is expanding in several important ways at ASH this year,” said
Data generated from the
“We’re encouraged to see the results of MRD testing with clonoSEQ in peripheral blood, which suggest that it is a prognostically significant assessment early in treatment,” said
In an MRD-adapted study from the
“The prognostic power of MRD has been well-substantiated, and now, a growing set of evidence supports the use of MRD to adapt approaches to therapy, with potentially meaningful implications on patients’ quality of life,” said
Additional Key clonoSEQ Data Presented at the Meeting:
Phase Ib/II Study of Multi-Targeted Therapy with Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide (ViPOR) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) (Abstract 434)
- In this study, clonoSEQ was used to monitor ctDNA following 6 cycles of ViPOR in 50 R/R DLBCL patients. Inferior PFS and overall survival (OS) were associated with an elevated ctDNA at baseline and detectable ctDNA during or at end of treatment, reinforcing the prognostic value of clonoSEQ in DLBCL.
A Multicenter Phase 2 Trial of Zanubrutinib, Obinutuzumab, and Venetoclax (BOVen) in Patients with Treatment-Naive, TP53-Mutant Mantle Cell Lymphoma (Abstract 738)
- This study investigated the efficacy and tolerability of the BOVen regimen (zanubrutinib [Zanu], Obinutuzumab [Obin], and venetoclax [Ven]) in high-risk MCL patients. Study outcomes included PFS and OS; MRD was assessed by clonoSEQ in peripheral blood. Patients who achieved complete remission and undetectable MRD after 24 cycles of BOVen discontinued treatment. This study shows how MRD assessment can identify deep responses to novel treatment regimens. Additionally, future outcomes data will elucidate the utility of MRD to guide treatment discontinuation in this population.
Post-CAR-T Minimal Residual Disease (MRD) Monitoring in Mantle Cell Lymphoma Enables Early Relapse Detection (Abstract 1673)
- In this real-world experience study, clonoSEQ was used to assess MRD in 34 MCL patients treated with brexu-cel. MRD positive patients had lower median PFS (10.74 months vs. 17.69 months) and 6 out of 7 relapses were preceded by an MRD positive test. 88% (15/17) of patients that were MRD negative at day 28 remained MRD negative at 6 months. This data reinforces that MRD status is a strong prognostic marker for relapse and durable remissions.
About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test service to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in
clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The assay provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematological malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, ALL and DLBCL.
For important information about the FDA-cleared uses of clonoSEQ, including sample types and test limitations, please visit www.clonoSEQ.com/technical-summary.
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