Adaptive Biotechnologies Included in More than 20 Abstracts at ASCO and EHA 2021 Highlighting Expanding Use Cases for MRD Tes...
June 03 2021 - 7:30AM
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, will be included in more than 20 abstracts studying
the use of Adaptive’s clonoSEQ® Assay for minimal residual disease
(MRD) assessment at the American Society of Clinical Oncology
(ASCO) Annual Meeting from June 4-8, and the European Hematology
Association (EHA) Virtual Congress from June 9-17. 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 (MM) and B-cell acute lymphoblastic leukemia
(B-ALL), and is widely available to clinicians and patients across
the U.S.
“What is particularly notable at ASCO and EHA this year is the
breadth of clinical use cases for MRD that are represented,” said
Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies.
“Both clinician investigators and pharmaceutical companies have
found new settings in which deep responses by clonoSEQ are
achievable, which is excellent news for patients and also evidence
of the growing role that clonoSEQ MRD monitoring can play across
the lymphoid cancer care continuum.”
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
information about how a patient may be responding to treatment, so
patients and providers can be in control when it comes to managing
the disease and treatment decisions.
Data at ASCO and EHA illustrates the relevance of MRD assessment
post-CAR T cell therapy, in MM patients who are often heavily
pretreated and who in the past might not have been expected to have
such deep responses. Similarly, data showing the ability to achieve
deep responses in high-risk patients supports the growing range of
patient settings in which MRD assessment is valuable. Both meetings
also include data showcasing the importance of serial monitoring of
MRD using clonoSEQ as a primary endpoint. These data demonstrate
that understanding the kinetics of low-level disease over time –
which can only be ascertained using a highly sensitive and
precisely quantitative MRD assay like clonoSEQ – is vital to
clinicians’ ability to accurately understand prognosis and even
more clinically meaningful than a single point-in-time
measurement.
Key presentations include:
|
Title |
Presentation Timing |
CLL |
EHA S146 (oral) |
Venetoclax-obinutuzumab for previously untreated chronic
lymphocytic leukemia: 4-year follow up analysis of the randomized
CLL14 study |
on demand |
Multiple Myeloma |
ASCO - 8005 (oral) |
Ciltacabtagene autoleucel, a B-cell maturation antigen
(BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy,
in relapsed/refractory multiple myeloma (R/R MM): Updated results
from CARTITUDE-1. |
Tuesday, June 8 8:00 AM - 11:00 AM EDT |
ASCO - 8016 (poster) |
Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T
cell therapy, in relapsed and refractory multiple myeloma: Updated
KarMMa results |
Friday, June 4 9:00 AM EDT |
ASCO - TPS 8054 |
Subcutaneous daratumumab (DARA SC) plus lenalidomide versus
lenalidomide alone as maintenance therapy in patients (pts) with
newly diagnosed multiple myeloma (NDMM) who are minimal residual
disease (MRD) positive after frontline autologous stem cell
transplant (ASCT): The phase 3 AURIGA study. |
Friday, June 4 9:00 AM EDT |
ASCO - 8011 (poster)/EHA EP1010 |
Interim analysis of a phase 2 minimal residual disease
(MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and
dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma
(MM). |
Friday, June 4 9:00 AM EDT/on demand |
ASCO - 8004 (oral) |
Daratumumab (DARA) maintenance or observation (OBS) after treatment
with bortezomib, thalidomide and dexamethasone (VTd) with or
without DARA and autologous stem cell transplant (ASCT) in patients
(pts) with newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part
2 |
Tuesday, June 8 8:00 AM - 11:00 AM EDT |
MCL |
7505 (oral) |
The combination of venetoclax, lenalidomide, and rituximab in
patients with newly diagnosed mantle cell lymphoma induces high
response rates and MRD undetectability. |
Monday, June 7 11:30 AM - 2:30 PM EDT |
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 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 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 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
these terms or other comparable terminology, although not all
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
Adaptive Biotechnologies (NASDAQ:ADPT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adaptive Biotechnologies (NASDAQ:ADPT)
Historical Stock Chart
From Sep 2023 to Sep 2024