Adaptive Biotechnologies Announces New Clinical Data Demonstrating Impact of clonoSEQ® Assay on Patients with Blood Cancers at the 62nd ASH Annual Meeting
MRD refers to the small number of cancer cells that can remain in a patient’s body after treatment, which often cause no signs or symptoms but eventually can lead to recurrence of the disease. These residual cells can be present at very low levels and require highly sensitive tests to identify them. clonoSEQ, which is the only FDA-cleared test for MRD assessment in lymphoid malignancies, is highly accurate, sensitive, and standardized compared to other technologies.
“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,” said
Real-world evidence generated by clinicians at the
“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,” said
Myeloma patient advocates agree that there are meaningful, practical real-world benefits for patients who undergo MRD testing.
“The ability to accurately monitor disease burden in multiple myeloma is critical when making decisions that impact each patient’s care,” said
Patients may also benefit from potential MRD-informed treatment changes which may reduce the cost of their care. Additionally, researchers from the
Additional Key clonoSEQ Data Presented at the Meeting:
Monitoring Measurable Residual Disease Using Peripheral Blood in Acute Lymphoblastic Leukemia: Results of a Prospective, Observational Study (Abstract 975)
- This prospective study investigated the prognostic and predictive utility of peripheral blood (PB) based MRD assessment in 62 ALL patients who received a cellular therapy.
- The study demonstrated a strong correlation between MRD assessed from PB and bone marrow (BM) using clonoSEQ, and concluded that less-invasive clonoSEQ MRD monitoring in PB represents an alternative to serial BM examinations in patients undergoing curative intent cellular therapies.
Clonal Dynamics after Venetoclax-Obinutuzumab Therapy: Novel Insights from the Randomized, Phase 3 CLL14 Trial (Abstract 127)
- This Phase 3 study evaluated MRD as a secondary endpoint in 432 CLL patients with previously untreated CLL and co-existing conditions who were randomized to receive chlorambucil or venetoclax in combination with obinutuzumab. MRD was assessed every 3-6 months in PB. The subset of data presented at ASH analyzes MRD and clonal growth patterns in both cohorts of patients to better understand disease dynamics during and after treatment.
- Results showed that clonal growth, a measure for how quickly cancer cells grow, was significantly lower after treatment with venetoclax plus obinutuzumab than after treatment with chlorambucil and obinutuzumab, indicating more effective MRD eradication and clonal growth modulation with venetoclax plus obinutuzumab. Additionally, 40% of patients in the venetoclax arm had undetectable MRD levels of <10-6 compared to just 7% of patients in the chlorambucil arm.
- This analysis of the trial data demonstrates that understanding patient-specific cancer growth rates in addition to MRD status may be helpful in informing treatment duration.
Frontline Sequential Immunochemotherapy Plus Lenalidomide for Mantle Cell Lymphoma Incorporating MRD Evaluation: Phase II, Investigator-Initiated, Single-Center Study (Abstract 119)
- This study evaluated frontline sequential immunochemotherapy plus lenalidomide for the treatment of patients with MCL.
- During the study, MRD testing with clonoSEQ was performed on PB after each phase of treatment and at six months post end of treatment.
- There was a high rate of MRD negativity after induction chemoimmunotherapy (Len-R-CHOP + R-HiDAC) at thresholds of 10-5 (97%) and 10-6 (80%), with the deepest responses (10-6) shown to be predictive of remission duration. Several patients converted from MRD-negative to MRD-positive at six months post-treatment and eventually relapsed, suggesting that a more prolonged period of maintenance may be beneficial.
About the clonoSEQ Assay
The clonoSEQ Assay is the first and only FDA-cleared assay for MRD in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) refers to the small number of cancer cells that can stay in the body during and after treatment. clonoSEQ was initially granted De Novo designation and marketing authorization by the FDA for the detection and monitoring of MRD in patients with MM and B-ALL using DNA from bone marrow samples. In August 2020, clonoSEQ received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL.
The clonoSEQ Assay leverages Adaptive’s 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 therapy over time, monitor patients during remission and predict potential relapse. 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 the clonoSEQ Assay in patients diagnosed with CLL, MM and ALL.
The clonoSEQ Assay is a single-site test performed at Adaptive Biotechnologies. In addition to its FDA-cleared uses, clonoSEQ is also available as a CLIA-validated laboratory developed test (LDT) service for use in other lymphoid cancers and sample types. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary.
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Source: Adaptive Biotechnologies