January 14, 2021
By Julie Gould
“With more specific and accurate information about a patient’s disease status or how that patient is responding to treatment, doctors can have more robust conversations with their patients about treatment goals, treatment effectiveness, and future prognosis,” says Lance Baldo, MD.
Hello, my name is Dr. Lance Baldo. I am the Chief Medical Officer at Adaptive Biotechnologies.
Adaptive Biotechnologies is a commercial stage biotechnology company focused on decoding the immune system to learn how it naturally detects and fights a multitude of diseases. The information about how it does this is held within the genetic code of T and B cell receptors. We have built a proprietary and powerful immune medicine platform that reads the genetic language of these receptors and translates it into data. This data can be used to develop clinical products to diagnose and treat many different diseases.
Our 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). In August 2020, clonoSEQ® received additional clearance from the FDA to detect and monitor MRD in blood or bone marrow from patients with CLL.
Can you briefly discuss minimal residual disease? How is it being used in research?
Minimal residual disease, also referred to as measurable residual disease or MRD, refers to the small number of cancer cells that can stay in the body during and after treatment. While MRD often causes no signs or symptoms, it 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.
MRD testing is used to measure the effectiveness of a therapy and is performed at specific points in a patients’ treatment. A positive result means residual disease was detected while a negative result means residual disease was not detected. Patients can gain valuable insights about their cancer regardless of whether they have a positive or negative result.
Our next-generation sequencing clonoSEQ® Assay is the only FDA-approved test for MRD assessment in patients with chronic lymphocytic leukemia (CLL), multiple myeloma and B-cell acute lymphoblastic leukemia (ALL), which can detect one single cancer cell among a million healthy cells.
One example of the use of clonoSEQ in research is seen in real- world evidence generated by clinicians at the University of California San Francisco (UCSF) and in Madrid, and presented at ASH, (abstract 2273). The results demonstrated that MRD-based decision-making with the clonoSEQ® Assay improved outcomes for multiple myeloma patients. The retrospective review evaluated 373 multiple myeloma patients from three health centers who had at least one MRD assessment. Physicians changed treatment for 58 of those patients based on their MRD status and ultimately those patients had a significantly improved progression free survival (PFS) compared to the patients whose treatment did not change (median PFS 97 vs. 75 months, P=0.006).
How does MRD help assess treatment outcomes and help determine disease management decisions? Why is this helpful and how does this help health care utilization?
Accurate and sensitive measurement of MRD allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and predict potential relapse.
With more specific and accurate information about a patient’s disease status or how that patient is responding to treatment, doctors can have more robust conversations with their patients about treatment goals, treatment effectiveness, and future prognosis. These conversations, combined with the insights provided by the MRD results, enable clinicians to better tailor their management approach to achieve the most optimal outcome for their patients with blood cancer. Additionally, early detection of returning cancer may allow patients and doctors to respond quickly to fight the disease, so that patients can confidently plan for what the future has in store for them.
What are the benefits of using this? How does it impact the future of care?
Treatment options for blood cancers like CLL, ALL and multiple myeloma have continued to rapidly advance in the last couple of decades with the introduction of more novel and targeted therapies, which are making deeper responses and longer-lasting remissions possible for more and more patients. Doctors can use MRD test results to help make sense of their options and how to best deploy them, which ultimately gives both physicians and patients confidence in these novel treatments and provides information to change the treatment course if needed.
MRD testing with clonoSEQ® could also enable cost savings for the healthcare system overall. A poster presentation at ASH (Abstract 3426) by researchers from the Winship Cancer Institute of Emory University, showed that based on savings of maintenance therapy costs or no longer requiring active treatment for relapsed/refractory (R/R) disease, MRD testing with clonoSEQ® provided estimated lifetime savings of $916,000 per patient annually for the institution.
Is there anything else you would like to add?
The data presented at ASH this year reflect the growing evidence supporting the ability of clonoSEQ® to provide meaningful benefits for patients with blood cancer in a variety of clinical settings. For a clinician like me, it is really encouraging to see that patients are seeing the benefits of MRD testing not only in clinical trials, but also in current clinical practice. I am happy to see clinicians increasingly utilizing clonoSEQ® to help guide day-to-day patient care.