FDA Clears clonoSEQ to Detect MRD in Chronic Lymphocytic Leukemia

Adaptive Biotechnologies received its third approval from the FDA for the use of its next-generation sequencing assay to detect minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL).

The assay, clonoSEQ, uses a proprietary immunosequencing platform to monitor for MRD, where a small number of cancer cells remain during and after treatment. It is difficult to detect without precise, sensitive tools, and can lead to a recurrence of disease.

The approval follows a decision by CMS in January to pay for cloneSEQ testing for CLL, in addition to multiple myeloma and B-cell acute lymphoblastic leukemia. Nearly 80% of US patients with CLL are age 65 or over.

“We know that traditional CLL treatment response criteria are insufficient, so the ability to measure MRD with a test that is one hundred times more sensitive than standard flow cytometry may change our approach to treating CLL,” John Pagel, MD, principal investigator and chief of Hematologic Malignancies at the Swedish Cancer Institute, said in a statement. “A patient’s MRD status gives us timely information about how a treatment is working, so patients and providers can be in the driver’s seat when it comes to managing their disease and treatment decisions.”

The decision announced Thursday was based on clinical validation data from 2 trials.

In an analysis of data from the CLL14 study (N = 337), patients with undetectable MRD in blood by clonoSEQ at 3 months post-treatment had a nearly 7-fold reduced risk of disease progression compared with patients who did not reach undetectable MRD. Undetectable MRD was defined at a level of 1 cancer cell among 100,000 healthy cells (10^-5).

At 30 months post-treatment, the probability of progression for evaluable patients with undetectable MRD was only 5%, as compared with 36% for patients with detectable disease.

In a second study, clonoSEQ MRD results were shown to be significantly predictive of outcomes in both blood and bone marrow samples, regardless of the threshold at which MRD was assessed.

In its announcement, Adaptive also released information about how patients can get tested during the coronavirus disease 2019 pandemic without going to a hospital or oncology clinic. Patients can get their blood drawn at home through Adaptive’s collaboration with Phlebotek Solutions, a nationwide provider of mobile phlebotomy services, or go to a LabCorp Patient Service Center.