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 real-world data highlighting the
clinical utility of Adaptive’s next-generation sequencing (NGS)
clonoSEQ® Assay to assess minimal residual disease (MRD) in
patients with multiple myeloma. The data are being presented at the
American Society of Hematology (ASH) 62nd Annual Meeting and
Exposition, held virtually December 5-8. Additional study results
demonstrating the impact of Adaptive’s clonoSEQ Assay in chronic
lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) and
mantle cell lymphoma (MCL) are also being presented at the meeting
in 45 other abstracts.
MRD refers to the small number of cancer cells that can remain
in a patient’s body after treatment, which often cause no signs or
symptoms but eventually can lead to recurrence of the disease.
These residual cells can be present at very low levels and require
highly sensitive tests to identify them. clonoSEQ, which is the
only FDA-cleared test for MRD assessment in lymphoid malignancies,
is highly accurate, sensitive, and standardized compared to other
technologies.
“The data presented at ASH this year reflect
the growing evidence supporting clonoSEQ’s ability to provide
meaningful benefit for patients with blood cancers in a variety of
clinical settings,” said Lance Baldo, MD, Chief Medical Officer of
Adaptive Biotechnologies. “It is increasingly clear that MRD
testing with clonoSEQ, utilizing our immune medicine platform, is
playing an important role in treatment decision-making which can
have a dramatic impact not only on patients, but could also enable
cost savings for the healthcare system overall.”
Real-world evidence generated by clinicians at the University of
California San Francisco (UCSF) and in Madrid demonstrated that
MRD-based decision-making with the clonoSEQ Assay improved outcomes
for multiple myeloma patients. This study will be presented in a
poster presentation titled, “Making
Clinical Decisions to Change Therapy Using Measurable Residual
Disease Improves the Outcome in Multiple Myeloma”
(Abstract 2273).
The retrospective review evaluated 373 multiple myeloma patients
from three health centers who had at least one MRD assessment. Of
the 373 patients, physicians made a clinical decision to change
treatment for 58 patients based on their MRD status. Results showed
that these 58 patients had a significantly improved
progression-free survival (PFS) versus patients who did not change
treatment (n=312) (median PFS 97 vs. 75 months, p=0.006).
“We are encouraged by these real-world data and the impact MRD
testing can have on the way we manage patients who have had great
but not perfect responses to therapy, and the way we can make
earlier decisions,” said Jeffrey Wolf, MD, Clinical Professor,
Department of Medicine, UCSF; and Director, Myeloma Program, UCSF
Helen Diller Family Comprehensive Cancer Center. “These results
support the integration of MRD assessment as a standard of care in
the management of multiple myeloma patients. MRD assessment allows
physicians and patients alike to have more confidence in their
treatment decisions.”
Myeloma patient advocates agree that there are meaningful,
practical real-world benefits for patients who undergo MRD
testing.
“The ability to accurately monitor disease burden in multiple
myeloma is critical when making decisions that impact each
patient’s care,” said Daniel Auclair, PhD, Chief Scientific Officer
of the Multiple Myeloma Research Foundation. “We are encouraged by
the data emerging in MRD assessment, which we believe will help
myeloma patients and their doctors better manage their
disease.”
Patients may also benefit from potential MRD-informed treatment
changes which may reduce the cost of their care. Additionally,
researchers from the Winship Cancer Institute of Emory University
will present results from a poster presentation titled
“Cost-Effectiveness of
Implementing clonoSEQ NGS-MRD
Testing Using the Emory MRD Decision Protocol in Multiple
Myeloma”
(Abstract 3426).
This study evaluated a framework which allowed patients with
sustained MRD negativity (defined as MRD <10-5 across two
assessments at least 12-months apart) to discontinue indefinite
maintenance therapy. Results showed that, based on savings of
maintenance therapy costs or no longer requiring active treatment
for relapsed/refractory (R/R) disease, MRD testing with clonoSEQ
provided estimated lifetime savings of $916,000 per patient
annually for the institution. Additionally, results showed MRD
testing with clonoSEQ resulted in improved health outcomes in
comparison to no testing (0.009 QALYs), primarily due to the
avoidance of treatment-related adverse events.
Additional Key clonoSEQ Data Presented at the
Meeting:
Monitoring Measurable Residual Disease Using Peripheral
Blood in Acute Lymphoblastic Leukemia: Results of a Prospective,
Observational Study (Abstract
975)
- This prospective study investigated the prognostic and
predictive utility of peripheral blood (PB) based MRD assessment in
62 ALL patients who received a cellular therapy.
- The study demonstrated a strong
correlation between MRD assessed from PB and bone marrow (BM) using
clonoSEQ, and concluded that less-invasive clonoSEQ MRD monitoring
in PB represents an alternative to serial BM examinations in
patients undergoing curative intent cellular therapies.
Clonal Dynamics after Venetoclax-Obinutuzumab Therapy:
Novel Insights from the Randomized, Phase 3 CLL14 Trial
(Abstract 127)
- This Phase 3 study evaluated MRD as a secondary endpoint in 432
CLL patients with previously untreated CLL and co-existing
conditions who were randomized to receive chlorambucil or
venetoclax in combination with obinutuzumab. MRD was assessed every
3-6 months in PB. The subset of data presented at ASH analyzes MRD
and clonal growth patterns in both cohorts of patients to better
understand disease dynamics during and after treatment.
- Results showed that clonal growth, a measure for how quickly
cancer cells grow, was significantly lower after treatment with
venetoclax plus obinutuzumab than after treatment with chlorambucil
and obinutuzumab, indicating more effective MRD eradication and
clonal growth modulation with venetoclax plus obinutuzumab.
Additionally, 40% of patients in the venetoclax arm had
undetectable MRD levels of <10-6 compared to just 7% of patients
in the chlorambucil arm.
- This analysis of the trial data demonstrates that understanding
patient-specific cancer growth rates in addition to MRD status may
be helpful in informing treatment duration.
Frontline Sequential Immunochemotherapy Plus
Lenalidomide for Mantle Cell Lymphoma Incorporating MRD Evaluation:
Phase II, Investigator-Initiated, Single-Center Study
(Abstract 119)
- This study evaluated frontline sequential immunochemotherapy
plus lenalidomide for the treatment of patients with MCL.
- During the study, MRD testing with clonoSEQ was performed on PB
after each phase of treatment and at six months post end of
treatment.
- There was a high rate of MRD negativity after induction
chemoimmunotherapy (Len-R-CHOP + R-HiDAC) at thresholds of 10-5
(97%) and 10-6 (80%), with the deepest responses (10-6) shown to be
predictive of remission duration. Several patients converted from
MRD-negative to MRD-positive at six months post-treatment and
eventually relapsed, suggesting that a more prolonged period of
maintenance may be beneficial.
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 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
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“intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,”
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forward-looking statements contain these words. These statements
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actual results, levels of activity, performance or achievements to
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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
Calzadilla201-396-1687Carrie Mendivil, Gilmartin
Groupinvestors@adaptivebiotech.com
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