Senior Vice President Charles Sang on Expanded FDA Clearance of clonoSEQ® in CLL
I’ve known far too many people who have received a cancer diagnosis, navigated the initial shock, and bravely taken on all of the ‘stuff’ that comes with it – finding the right clinician, deciding on a treatment plan, and readjusting their life to the unknown.
What if my treatment stops working? What happens if my cancer returns? How long will I stay in remission?
Treatment for blood cancers has evolved rapidly, and the measure of minimal residual disease, or MRD, is becoming an increasingly important measure of the presence of cancer throughout the treatment journey. And now, patients living with the most common type of leukemia – chronic lymphocytic leukemia, or CLL – have a new way to get answers to those common questions that often keep them and their loved ones awake at night.
Today, Adaptive received FDA clearance for the clonoSEQ® Assay to assess MRD in CLL, expanding the existing label to a third indication – and providing an important advancement for this community. It is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL, with the ability to measure 1 cancer cell among 1,000,000 healthy cells. This next-generation sequencing assay identifies the genetic sequence for each patient’s unique T or B cell cancer, and then counts the number of these cancer cells when needed, during and after treatment.
This clearance comes at a pivotal time. As newer CLL therapies drive deeper response, MRD testing is increasingly important to assess depth and durability of response.
The FDA’s decision was based on samples and outcomes data from two clinical trials which demonstrated:
• CLL patients with undetectable MRD (U-MRD) as measured by clonoSEQ had significantly reduced risk of disease progression compared to patients who did not reach U-MRD status. Patients with U-MRD (MRD < 10-5) by clonoSEQ had a nearly 7-fold decreased risk of disease progression, compared to MRD-positive patients (MRD ≥ 10-5).2
• clonoSEQ MRD results were significantly predictive of progression-free survival (PFS) in both blood and bone marrow samples, regardless of the threshold at which MRD was assessed.2
The CLL treatment landscape has changed dramatically in the last decade, with many new therapies available and a host of promising treatments on the horizon. Patients are living longer because of these advancements and as a result, clinicians need new ways to more accurately assess efficacy earlier in the patient’s treatment journey, either on approved therapies or in clinical trials for new drugs in development.
While clonoSEQ has been used for quite some time from a patient’s bone marrow in multiple myeloma and B-cell acute lymphoblastic leukemia, today’s additional indication in blood as well as bone marrow for CLL patients provides that patient population options for assessing MRD. Blood-based testing, available for the first time as an FDA-cleared use of clonoSEQ, provides patients and healthcare providers with a more convenient and less intrusive option to detect and monitor disease. This is especially advantageous during the time of COVID-19; as we all know too well, cancer doesn’t stop for anything, even a pandemic.
We believe that the value of knowing your clonoSEQ MRD status can be valuable to any patient with these types of blood cancers. To ensure patients have access to testing, Medicare coverage for clonoSEQ was expanded to include testing for patients with CLL in addition to patients with myeloma and ALL. The Medicare CLL coverage policy closely aligns with CLL clinical practice guidelines and supports testing in both blood and bone marrow at time points throughout a patient’s treatment.
There is no easy way to get through a cancer diagnosis and journey. But the ability to know how many cancer cells remain during and following treatment can bring peace-of-mind during a very stressful experience. We are humbled to play a small role in helping to improve patient care in this meaningful way.