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, together with its collaborators will present data
from more than 35 abstracts studying the use of Adaptive’s
clonoSEQ® Assay for minimal residual disease (MRD) assessment at
the American Society of Hematology (ASH) virtual 62nd Annual
Meeting and Exposition, December 5-8. clonoSEQ is the first and
only U.S. Food and Drug Administration (FDA)-cleared assay for MRD
assessment in chronic lymphocytic leukemia (CLL), multiple myeloma
and B-cell acute lymphoblastic leukemia (B-ALL) and is widely
available to clinicians and patients across the U.S.
“We are thrilled to see so many investigators presenting
clonoSEQ data at ASH this year, among the more than 300 ASH studies
highlighting MRD data, significantly growing the body of evidence
validating this tool as a critical measure of patient outcomes,”
said Lance Baldo, MD, Chief Medical Officer of Adaptive
Biotechnologies. “As innovation continues for the treatment of
blood cancers with novel and highly targeted therapies that create
deep and durable responses for patients, we see clinicians
increasingly utilizing clonoSEQ to help guide day-to-day patient
care.”
Assessment of MRD is a way to directly detect and quantify
remaining disease, even in the absence of symptoms, across a
spectrum of blood cancers. A patient’s MRD status gives clinicians
timely information about how a patient may be responding to
treatment, so patients and providers can be in control when it
comes to managing their disease and treatment decisions.
clonoSEQ, the first clinical application of Adaptive’s immune
medicine platform, will be featured in 14 oral presentations and 23
posters at ASH. Data on clinical and research utility from studies,
as well as findings based on real-world experience, will be
presented across a range of cancers including multiple myeloma,
ALL, CLL and non-Hodgkin’s lymphoma (NHL). These new data show a
correlation between clonoSEQ MRD results and improved blood cancer
patient outcomes, enhanced clinical decision-making, and potential
savings to the healthcare system.
Additional data at ASH this year will highlight Adaptive’s
immune profiling research tool, immunoSEQ®, to quantitatively
assess the immune response to novel therapies in development.
Key presentations include:
Abstract |
Title |
Presentation Timing |
Oral Presentations |
Acute Lymphoblastic Leukemia |
583 |
Ultrasensitive Next-Generation Sequencing-Based Measurable Residual
Disease Assessment in Philadelphia Chromosome-Negative Acute
Lymphoblastic Leukemia after Frontline Therapy: Correlation with
Flow Cytometry and Impact on Clinical Outcomes |
Monday, December 7, 2020: 9:15 AM |
Chronic Lymphocytic Leukemia |
127 |
Clonal Dynamics after Venetoclax-Obinutuzumab Therapy: Novel
Insights from the Randomized, Phase 3 CLL14 Trial |
Saturday, December 5, 2020: 10:30 AM |
544 |
Transcend CLL 004: Phase 1 Cohort of Lisocabtagene Maraleucel
(liso-cel) in Combination with Ibrutinib for Patients with
Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small
Lymphocytic Lymphoma (CLL/SLL) |
Monday, December 7, 2020: 7:30 AM |
546 |
Updated Follow-up of Patients with Relapsed/Refractory Chronic
Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated with
Lisocabtagene Maraleucel in the Phase 1 Monotherapy Cohort of
Transcend CLL 004, Including High-Risk and Ibrutinib-Treated
Patients |
Monday, December 7, 2020: 8:00 AM |
Diffuse Large B-Cell Lymphoma |
531 |
Prognostic Value of Circulating Tumor DNA (ctDNA) in Autologous
Stem Cell Graft and Post-Transplant Plasma Samples Among Patients
with Diffuse Large B-Cell Lymphoma |
Monday, December 7, 2020: 7:15 AM |
Graft-Versus-Host-Disease |
730 |
TCR Repertoires in Graft-Versus-Host-Disease (GVHD)-Target Tissues
Reveals Tissue Specificity of the Alloimmune Response |
Monday, December 7, 2020: 1:30 PM |
Lymphoma |
530 |
Cerebrospinal Fluid (CSF) Analysis of Tumor-Specific Cell-Free DNA
(cfDNA) As a Diagnostic and Prognostic Tool for Central Nervous
System (CNS) Invasion in Lymphoma |
Monday, December 7, 2020: 7:00 AM |
Mantle Cell Lymphoma |
119 |
Frontline Sequential Immunochemotherapy Plus Lenalidomide for
Mantle Cell Lymphoma Incorporating MRD Evaluation: Phase II,
Investigator-Initiated, Single-Center Study |
Saturday, December 5, 2020: 10:00 AM |
Multiple Myeloma |
143 |
Early Versus Late Autologous Stem Cell Transplant in Newly
Diagnosed Multiple Myeloma: Long-Term Follow-up Analysis of the IFM
2009 Trial |
Saturday, December 5, 2020: 10:00 AM |
722 |
Spatiotemporal Assessment of Immunogenomic Heterogeneity in
Multiple Myeloma |
Monday, December 7, 2020: 2:15 PM |
Poster Presentations |
Acute Lymphoblastic Leukemia |
975 |
Monitoring Measurable Residual Disease Using Peripheral Blood in
Acute Lymphoblastic Leukemia: Results of a Prospective,
Observational Study |
Saturday, December 5, 2020, 7:00 AM-3:30 PM |
Cutaneous T-Cell Lymphoma |
2082 |
Patient Characteristics of Long-Term Responders to Mogamulizumab:
Results from the MAVORIC Study |
Sunday, December 6, 2020, 7:00 AM-3:30 PM |
Diffuse Large B-Cell Lymphoma |
1450 |
Blinatumomab Consolidation Post Autologous Hematopoietic Stem Cell
Transplantation in Patients with Diffuse Large B Cell Lymphoma |
Saturday, December 5, 2020, 7:00 AM-3:30 PM |
Mantle Cell Lymphoma |
3031 |
Ibrutinib Maintenance (I-M) Following Intensive Induction in Mantle
Cell Lymphoma (MCL): Efficacy, Safety and Changes in Minimal
Residual Disease |
Monday, December 7, 2020, 7:00 AM-3:30 PM |
Multiple Myeloma |
1328 |
Improving the Definition of Response Assessment: Prognostic Value
of Minimal Residual Disease Combined with PET/CT at Day 100 Post
Autologous Stem Cell Transplantation in Multiple Myeloma |
Saturday, December 5, 2020, 7:00 AM-3:30 PM |
1592 |
Role of clonoSEQ®, a Next-Generation Sequencing (NGS) Assay and
PET/CT As a Measure of Minimal Residual Disease Negativity Among
Patients with Multiple Myeloma |
Saturday, December 5, 2020, 7:00 AM-3:30 PM |
2237 |
Making Clinical Decisions to Change Therapy Using Measurable
Residual Disease Improves the Outcome in Multiple Myeloma |
Sunday, December 6, 2020, 7:00 AM-3:30 PM |
3426 |
Cost-Effectiveness of Implementing Clonoseq NGS-MRD Testing Using
the Emory MRD Decision Protocol in Multiple Myeloma |
Monday, December 7, 2020, 7:00 AM-3:30 PM |
3156 |
Minimal Residual Disease in Multiple Myeloma: Targeted Mass
Spectrometry in Blood Vs Next Generation Sequencing in Bone
Marrow |
Monday, December 7, 2020, 7:00 AM-3:30 PM |
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 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.
About immunoSEQ
Assay Adaptive’s immunoSEQ Assay helps researchers
make discoveries in areas such as oncology, autoimmune disorders,
infectious diseases and basic immunology. The immunoSEQ Assay can
identify millions of T- and B-cell receptors from a single sample
in exquisite detail. Offered as a Service or Kit, the immunoSEQ
Assay is used to ask and answer translational research questions
and discover new prognostic and diagnostic signals in clinical
trials. The immunoSEQ Assay provides quantitative, reproducible
sequencing results along with access to powerful, easy-to-use
analysis tools. The immunoSEQ Assay is for research use only and is
not for use in diagnostic procedures.
About AdaptiveAdaptive 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 two 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 Statements This press release
contains forward-looking statements that are based on management’s
beliefs and assumptions and on information currently available to
management. All statements contained in this release other than
statements of historical fact are forward-looking statements,
including statements regarding our ability to develop,
commercialize and achieve market acceptance of our current and
planned products and services, our research and development
efforts, and other matters regarding our business strategies, use
of capital, results of operations and financial position, and plans
and objectives for future operations.
In some cases, you can identify forward-looking statements by
the words “may,” “will,” “could,” “would,” “should,” “expect,”
“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “ongoing” or the negative of
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forward-looking statements contain these words. These statements
involve risks, uncertainties and other factors that may cause
actual results, levels of activity, performance or achievements to
be materially different from the information expressed or implied
by these forward-looking statements. These risks, uncertainties and
other factors are described under "Risk Factors," "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and elsewhere in the documents we file with
the Securities and Exchange Commission from time to time.
We caution you that forward-looking statements are based on a
combination of facts and factors currently known by us and our
projections of the future, about which we cannot be certain. As a
result, the forward-looking statements may not prove to be
accurate. The forward-looking statements in this press release
represent our views as of the date hereof. We undertake no
obligation to update any forward-looking statements for any reason,
except as required by law.
MEDIA CONTACT:Beth
Keshishian917-912-7195media@adaptivebiotech.com
ADAPTIVE INVESTORS:Karina
Calzadilla201-396-1687
Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
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