Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial
stage biotechnology company that aims to translate the genetics of
the adaptive immune system into clinical products to diagnose and
treat disease, today announced new data highlighting the clinical
utility of Adaptive’s next-generation sequencing (NGS)-based
clonoSEQ® Assay to assess minimal residual disease (MRD) in
patients with multiple myeloma (MM) and chronic lymphocytic
leukemia (CLL). The data are being presented at the American
Society of Hematology (ASH) 63rd Annual Meeting and Exposition,
held December 11-14 as a hybrid event, in Atlanta and virtually.
MRD refers to the cancer cells that can remain in a patient’s
body after treatment. MRD may not cause symptoms, but the presence
of even a small number of cells may ultimately predict clinical
relapse. These residual cells can be present at very low levels and
require highly sensitive tests like clonoSEQ to identify them.
Data generated from an analysis of the MASTER trial showed that
regularly evaluating the MRD status of patients with newly
diagnosed MM (NDMM) allowed confident and successful treatment
discontinuation. This data was presented in an oral presentation
titled, “Daratumumab, Carfilzomib, Lenalidomide and
Dexamethasone (Dara-KRd), Autologous Transplantation and MRD
Response-Adapted Consolidation and Treatment Cessation. Final
Primary Endpoint Analysis of the Master Trial”
(Abstract
481). The study
evaluated 123 patients who were treated with the combination of
daratumumab, carfilzomib, lenalidomide and dexamethasone
(Dara-KRd) over 30 months. MRD was assessed utilizing clonoSEQ
in 118 patients. Of those, 84 patients (71%) achieved two
consecutive MRD-negative results <10-5, which facilitated
subsequent treatment discontinuation and entry into the MRD
surveillance (MRD-SURE) phase of the study. MRD follow-up for
MRD-SURE patients occurred at six months after treatment cessation
and then on an annual basis. At 12 months post treatment cessation,
the risk of MRD resurgence was 4% for patients with standard or
high-risk cytogenetic abnormalities (HRCA).
“Ongoing assessment of MRD status is critical in multiple
myeloma and should be considered as a part of every physician’s
treatment plan. We were thrilled to see that so many patients in
this study achieved deep MRD-negative responses and were therefore
able to stop treatment knowing that disease recurrence could be
closely monitored,” said Luciano Costa, MD, PhD, Principal
Investigator from O’Neal Comprehensive Cancer Center at the
University of Alabama at Birmingham. “As evidenced by this data,
MRD can guide therapy. The resulting relief from the burden of
ongoing maintenance therapy has the potential for profound impact
on myeloma patients’ quality of life.”
In Phase 2 results from a poster presentation titled,
“Zanubrutinib, Obinutuzumab, and Venetoclax in Chronic
Lymphocytic Leukemia: Early MRD Kinetics Define a High-Risk Patient
Cohort with Delayed Bone Marrow Undetectable MRD and Earlier
Post-Treatment MRD Recurrence”
(Abstract
3753), undetectable MRD (uMRD) was
assessed from the peripheral blood (PB) and bone marrow (BM) of 39
patients with relapsed or refractory CLL to determine the duration
of a regimen including zanubrutinib, obinutuzumab and venetoclax
(BOVen). 33 patients stopped therapy based on predefined uMRD
criteria. Of those, 94% remained MRD-negative after a median of 15
months without treatment. clonoSEQ was used to demonstrate that a
>400-fold decrease in MRD from PB after 4 months was highly
predictive of achieving uMRD in the BM in <8 months. These data
support further investigation of the use of kinetics of early
response with clonoSEQ to discontinue therapy.
“We found that BOVen achieved frequent, durable uMRD responses
in previously untreated patients with CLL, with 89% of patients
achieving uMRD in both the blood and bone marrow and stopping
therapy after a median of 10 months,” said Jacob Soumerai, MD,
Center for Lymphoma, Massachusetts General Hospital Cancer Center.
“Importantly, the MRD kinetics data presented at ASH suggest that
it’s not just whether or not you achieve uMRD, but rather that
early MRD response kinetics might predict MRD outcomes and define
biologic differences.”
clonoSEQ represents a standard of care in MRD assessment, as
evidenced by a significant volume of clonoSEQ data presented at the
2021 ASH Annual Meeting, including 22 various studies by
pharmaceutical companies leveraging MRD with clonoSEQ to determine
depth of response and stratify patient risk across blood cancers.
Notably, clonoSEQ was used to measure deep and durable responses in
patients in both the GLOW study (Abstract 70) and GRIFFIN study
(Abstract 79).
“We are pleased to see clonoSEQ being used as the standard for
MRD assessment in so many important presentations at this year’s
ASH annual meeting,” said Lance Baldo, MD, Chief Medical Officer of
Adaptive Biotechnologies. “Understanding MRD levels and trends over
time is critical to the care of patients living with blood cancers,
and clonoSEQ’s unique ability to deliver sensitive, specific and
standardized MRD results has proven valuable in informing treatment
decisions, including extending and discontinuing therapy, that lead
to excellent patient outcomes across multiple types of blood
cancers.”
About the clonoSEQ AssayThe 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 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 MRD assessment in other lymphoid cancers and sample
types, as well as for determination of IGHV mutation status in
CLL/SLL patients. 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.
About Adaptive BiotechnologiesAdaptive
Biotechnologies is a commercial-stage biotechnology company
focused on harnessing the inherent biology of the adaptive immune
system to transform the diagnosis and treatment of disease. We
believe the adaptive immune system is nature’s most finely tuned
diagnostic and therapeutic for most diseases, but the inability to
decode it has prevented the medical community from fully leveraging
its capabilities. Our proprietary immune medicine platform reveals
and translates the massive genetics of the adaptive immune system
with scale, precision and speed to develop products in life
sciences research, clinical diagnostics and drug discovery. We have
three commercial products and a robust clinical pipeline to
diagnose, monitor and enable the treatment of diseases such as
cancer, autoimmune conditions and infectious diseases. Our goal is
to develop and commercialize immune-driven clinical products
tailored to each individual patient. For more information, please
visit adaptivebiotech.com and follow us
on www.twitter.com/adaptivebiotech.Forward Looking
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MEDIA CONTACT:Erica
Schmitt206-279-2423media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina Calzadilla, Vice
President, Investor Relations201-396-1687Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
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