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 30 abstracts demonstrating the actionability of
Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® test in
assessing minimal residual disease (MRD) in blood cancer patients
at the 65th Annual Meeting of the American Society of Hematology
(ASH), December 9-12 in San Diego, California.
clonoSEQ is the only U.S. Food and Drug Administration
(FDA)-cleared test to detect MRD in bone marrow from patients with
multiple myeloma (MM) or B-cell acute lymphoblastic leukemia
(B-ALL) and blood or bone marrow from patients with chronic
lymphocytic leukemia (CLL). clonoSEQ testing for other lymphoid
malignancies, including diffuse large B-cell lymphoma (DLBCL),
mantle cell lymphoma (MCL) and follicular lymphoma (FL) is
currently available for clinical use as a laboratory-developed test
(LDT) performed at Adaptive's CLIA-certified lab in Seattle,
Washington.
“Data continue to mount which reinforce the prognostic value of
MRD and highlight its growing role in the blood cancer treatment
landscape,” said Susan Bobulsky, Senior Vice President,
Diagnostics, Adaptive Biotechnologies. “clonoSEQ provides
actionable insights which are guiding the personalization of care
for blood cancer patients today, as well as shaping the future of
blood cancer treatment by supporting the development of
cutting-edge therapeutics.”
Minimal residual disease – also referred to as measurable
residual disease – is one of the strongest predictors of outcomes
in blood cancers and routine testing provides a personalized way to
track a patient’s individual response to treatment and inform
shared decision-making to optimize care. In addition to clinical
use, MRD testing is widely used in drug development to get an early
read on efficacy to inform patient stratification and increasingly
as a trial endpoint.
Data supporting clonoSEQ’s clinical and research utility, as
well as insights based on analysis of real-world experience, will
be featured in a late-breaking presentation, eight oral
presentations and 24 posters across lymphoid malignancies. Studies
will be presented demonstrating the clinical actionability of MRD
testing across disease states. Notably, data illustrating the
prognostic value of clonoSEQ MRD assessment using peripheral blood
in MM and from circulating tumor DNA (ctDNA) in DLBCL will also be
presented. Additionally, biopharmaceutical companies and other
investigators will share data from 13 studies using clonoSEQ as an
endpoint to measure deep responses during or after therapy,
including novel treatment regimens such as CAR T-cell therapies and
bispecifics.
To advance biopharmaceutical partner research, Adaptive recently
made available a new version of the ctDNA-based assay to assess MRD
in DLBCL clinical trials. The research use only (RUO) assay has
increased sensitivity to enable MRD assessment in clinical trials
at the end of treatment timepoint (EOT) when disease burden is
lowest as well as in post-treatment surveillance and later lines of
therapy.
Abstract |
Title |
Presentation Timing |
Late-Breaking Abstract |
LBA-1 |
Phase 3 Randomized Study of Daratumumab (DARA) + Bortezomib,
Lenalidomide, and Dexamethasone (VRd) Versus Vrd Alone in Patients
(Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Who Are Eligible
for Autologous Stem Cell Transplantation (ASCT): Primary Results of
the Perseus Trial |
Tuesday, December 12, 2023, 9:00 AM-10:30 AM |
Oral Presentations |
Chronic Lymphocytic Leukemia |
330 |
Lisocabtagene Maraleucel (liso-cel) in R/R CLL/SLL: 24-Month Median
Follow-up of TRANSCEND CLL 004 |
Saturday, December 9, 2023: 5:15 PM |
634 |
First-Line Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven)
Versus Chlorambucil Plus Obinutuzumab (Clb+O): 55-Month Follow-up
from the Glow Study |
Sunday, December 10, 2023: 5:15 PM |
Diffuse Large B-Cell Lymphoma |
434 |
Phase Ib/II Study of Multi-Targeted Therapy with Venetoclax,
Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide (ViPOR) in
Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma
(DLBCL) |
Sunday, December 10, 2023: 9:45 AM |
Mantle Cell Lymphoma |
738 |
A Multicenter Phase 2 Trial of Zanubrutinib, Obinutuzumab, and
Venetoclax (BOVen) in Patients with
Treatment-Naive, TP53-Mutant Mantle Cell Lymphoma |
Monday, December 11, 2023: 11:45 AM |
1024 |
Adaptive Manufacturing of LV20.19 CAR T-Cells for Relapsed,
Refractory Mantle Cell Lymphoma |
Monday, December 11, 2023: 5:15 PM |
Multiple Myeloma |
205 |
Carfilzomib-Lenalidomide-Dexamethasone (KRd) Vs.
Lenalidomide-Dexamethasone (Rd) in Newly Diagnosed Fit or
Intermediate-Fit Multiple Myeloma Patients Not Eligible for
Autologous Stem-Cell Transplantation (Phase III EMN20 Trial):
Analysis of Sustained Undetectable Minimal Residual Disease
(MRD) |
Saturday, December 9, 2023: 2:00 PM |
338 |
Venetoclax in Combination with Daratumumab and Dexamethasone
Elicits Deep, Durable Responses in Patients with t(11;14)
Relapsed/Refractory Multiple Myeloma: Updated Analyses of Minimal
Residual Disease Negativity in Phase 1/2 Study |
Saturday, December 9, 2023: 4:15 PM |
1028 |
Idecabtagene Vicleucel (ide-cel) Versus Standard (std) Regimens in
Patients (pts) with Triple-Class-Exposed (TCE) Relapsed and
Refractory Multiple Myeloma (RRMM): Updated Analysis from
KarMMa-3 |
Monday, December 11, 2023: 4:45 PM |
Poster Presentations |
AL Amyloidosis |
3398 |
Using Next Generation Sequencing to Identify Trackable Clonotypic
Sequences for Minimal Residual Disease Testing in AL
Amyloidosis |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
B-Cell Acute Lymphoblastic Leukemia |
4847 |
Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2
(P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By
Cellectis Biologics, in Patients with Relapsed or Refractory (R/R)
CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
Monday, December 11, 2023, 6:00 PM-8:00 PM |
Chronic Lymphocytic Leukemia |
3257 |
Multilayer Profiling of MRD in Patients with Relapsed/Refractory
CLL Treated with Venetoclax-Based Regimens in a Real-World
Setting |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
3263 |
Undetectable MRD Status in Patients with R/R CLL/SLL with Stable
Disease after Lisocabtagene Maraleucel Treatment: Exploratory
Analysis of the TRANSCEND CLL 004 Study |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
3269 |
Fixed-Duration Pirtobrutinib Combined with Venetoclax ± Rituximab
in Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated
Results, Including MRD Data, from the BRUIN Phase 1b Study |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
Diffuse Large B-Cell Lymphoma |
5029 |
Impact of Sequence Uniqueness on MRD Monitoring in NGS
Immunoglobulin Sequencing: An Analysis of Ig Loci Among >1200
Diffuse Large B-Cell Lymphoma Patients Tested By ClonoSEQ |
Monday, December 11, 2023, 6:00 PM-8:00 PM |
Follicular Lymphoma |
1655 |
Epcoritamab SC Monotherapy Leads to Deep and Durable Responses in
Patients with Relapsed or Refractory Follicular Lymphoma: First
Data Disclosure from the Epcore NHL-1 Follicular Lymphoma
Dose-Expansion Cohort |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
4359 |
Minimal Residual Disease (MRD) Status Predicts Outcomes in Patients
with Follicular Lymphoma (FL) Treated with Chemo-Immunotherapy on
SWOG S0016 |
Monday, December 11, 2023, 6:00 PM-8:00 PM |
Mantle Cell Lymphoma |
1673 |
Post-CAR-T Minimal Residual Disease (MRD) Monitoring in Mantle Cell
Lymphoma Enables Early Relapse Detection |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
3036 |
Acalabrutinib with Rituximab As First-Line Therapy for Older
Patients with Mantle Cell Lymphoma – a Phase II Clinical Trial |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
4407 |
Minimal Residual Disease (MRD) Testing By Next Generation
Sequencing (NGS) after Two Cycles (CY) of Non-Intensive
Chemoimmunotherapy Is Predictive of Remission Duration and Need for
Maintenance Therapy (MT) in Previously Untreated Mantle Cell
Lymphoma (MCL): A Wisconsin Oncology Network Study |
Monday, December 11, 2023, 6:00 PM-8:00 PM |
Multiple Myeloma |
1982 |
Early Peripheral Blood Minimal Residual Disease Status By NGS in
Patients with Newly Diagnosed Multiple Myeloma (MM) on a Phase 2
Trial Receiving Elotuzumab, Carfilzomib, Lenalidomide, and
Dexamethasone (Elo-KRd) |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
2101 |
Efficacy and Safety of Idecabtagene Vicleucel (ide-cel) in Patients
with Clinical High-Risk Newly Diagnosed Multiple Myeloma (NDMM)
with an Inadequate Response to Frontline Autologous Stem Cell
Transplantation (ASCT): KarMMa-2 Cohort 2c Extended Follow-up |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
2214 |
Patterns of Change in Multiple Myeloma (MM) Clone Size with
Autologous Hematopoietic Stem Cell Transplantation (ASCT) Assessed
By Next Generation Sequencing (NGS) in Patients (pts) Receiving
Modern Therapy |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
2339 |
MRD Assessment in Patients with Newly Diagnosed Multiple Myeloma
Using Tokenized Real World Data Sources |
Saturday, December 9, 2023, 5:30 PM-7:30 PM |
3351 |
Teclistamab Induces Favorable Responses in Patients with Relapsed
and Refractory Multiple Myeloma after Prior BCMA-Directed
Therapy |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
3380 |
Primary Endpoint Analysis from a Response Adaptive Phase II
Clinical Trial of Carfilzomib, Lenalidomide, Dexamethasone Plus
Daratumumab (KRd-Dara) in Patients with Newly Diagnosed Multiple
Myeloma (NDMM) |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
3385 |
Long-Term Efficacy and Safety of Elranatamab Monotherapy in the
Phase 2 Magnetismm-3 Trial in Relapsed or Refractory Multiple
Myeloma (RRMM) |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
3389 |
Sequential T-Cell Engagement for Myeloma (“STEM”) Trial: A Phase 2
Study of Cevostamab Consolidation Following BCMA CAR T Cell
Therapy |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
4671 |
A Phase II Study of Isatuximab, Once Weekly Carfilzomib,
Lenalidomide, Dexamethasone, in Newly Diagnosed,
Transplant-Eligible Multiple Myeloma (The SKylaRk Trial) |
Monday, December 11, 2023, 6:00 PM-8:00 PM |
4715 |
Longitudinal Assessment of Minimal Residual Disease (MRD) in the
ATLAS Randomized Phase 3 Trial of Post-Transplant Treatment with
Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Versus
Lenalidomide (R) Alone in Patients with Newly Diagnosed Multiple
Myeloma (NDMM) |
Monday, December 11, 2023, 6:00-8:00 PM |
4747 |
Final Analysis of a Phase 2 Trial of Daratumumab, Carfilzomib,
Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma
(NDMM) without Autologous Stem Cell Transplantation (ASCT) |
Monday, December 11, 2023, 6:00-8:00 PM |
Smoldering Multiple Myeloma |
3382 |
Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and
Dexamethasone in High-Risk Smoldering Multiple Myeloma |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
Lymphoid Malignancies (ALL, CLL, MM, DLBCL, MCL,
FL) |
3777 |
Update for the "Watch" Registry, a Real-World Observational Study
Using clonoSEQ® to Monitor MRD in Lymphoid Malignancies |
Sunday, December 10, 2023, 6:00 PM-8:00 PM |
clonoSEQ leverages Adaptive Biotechnologies’ 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 treatment, inform
changes in therapy, monitor disease burden over time, and detect
potential relapse early. 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 clonoSEQ in patients diagnosed with CLL, MM,
ALL and DLBCL.
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.
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