Adaptive Biotechnologies Announces Data Supporting the Clinical Benefits of MRD Assessment with clonoSEQ® To Be Presented at the Upcoming 2024 ASCO Annual Meeting and EHA2024 Hybrid Congress
2024年5月31日 - 8:30PM
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, announced that its next-generation sequencing
(NGS)-based clonoSEQ® test for measurable residual disease (MRD)
assessment will be included in several oral and poster
presentations at the American Society of Clinical Oncology (ASCO)
Annual Meeting taking place May 31-June 4 in Chicago and at the
European Hematology Association (EHA) Hybrid Congress taking place
June 13-16 in Madrid and virtually.
“The data that will be presented at ASCO and EHA this year build
on the expansive evidence base supporting the clinical significance
and actionability of MRD testing with clonoSEQ within the quickly
evolving blood cancer treatment landscape,” said Susan Bobulsky,
chief commercial officer, MRD, Adaptive Biotechnologies. “clonoSEQ
continues to be the gold standard in MRD assessment, empowering
clinicians with the most reliable insights to navigate complex
treatment decisions and arming drug developers with a highly
sensitive and standardized assay to confidently advance the most
promising therapeutics.”
MRD status is a powerful predictor of outcomes in blood cancers.
Routine MRD testing offers a personalized approach to monitor and
evaluate an individual’s response to treatment, identify early
signs of relapse before symptoms occur, and inform shared
decision-making to optimize care. Beyond clinical applications,
clonoSEQ assay technology is used extensively in drug development
as a robustly validated tool to understand treatment efficacy and
determine depth and kinetics of response. It is also increasingly
being used as a primary endpoint in clinical trials.
The clinical trial data and real-world evidence to be presented
at ASCO and EHA further underscore the clinical benefit of specific
and sensitive MRD assessment with clonoSEQ. Highlights include:
- In a Children’s Oncology Group-led study of pediatric patients
with acute lymphoblastic leukemia (ALL), evidence from the largest
analysis to date comparing bone marrow MRD assessment to peripheral
blood MRD assessment with clonoSEQ showed a strong correlation
between blood and marrow, independent of patient risk group. These
data support the potential for a less invasive method to monitor
MRD and track a patient’s response to therapy in ALL.
- In various stages of multiple myeloma (MM), real-world evidence
and clinical trial results reinforced the clinical significance of
sustained MRD negativity and importance of depth of response in
predicting patient outcomes, including overall survival (OS) and
progression-free survival (PFS), and illustrated how clonoSEQ could
inform treatment discontinuation or de-escalation decisions.
- Follow-up data generated from the University of Chicago
prospective MRD2STOP study indicated that MRD testing with clonoSEQ
at 10–6 may help identify patients who can safely and effectively
discontinue maintenance therapy and sustain MRD negativity off
treatment.
- An MRD analysis from the PERSEUS study, conducted by the Cancer
Center Clinica Universidad de Navarra in Spain, compared
bortezomib/lenalidomide/dexamethasone (VRd) with or without
daratumumab (D) in transplant-eligible patients with newly
diagnosed MM. MRD negativity at both 10–5 and 10–6 was
associated with improved PFS. Of note, the higher rates of deeper
responses (10–6) in the D-VRd/D-R arm were associated with a
clinically meaningful benefit of improved PFS.
- Multiple trials evaluating the safety and efficacy of novel
chimeric antigen receptor T cell (CAR-T) therapies demonstrated the
value of utilizing clonoSEQ to measure deep responses during or
after therapy in often difficult-to-treat patient populations and
showed MRD negativity as assessed by clonoSEQ testing is associated
with PFS.
- In patients with chronic lymphocytic leukemia (CLL), data from
clinical trials highlighted the use of clonoSEQ to support
individualized MRD-guided treatment modification.
clonoSEQ-related data to be presented at both ASCO and
EHA:
Presentation Type and Number |
Title |
Presentation Timing |
B-Cell Acute Lymphoblastic Leukemia |
ASCO Oral Presentation6504 |
Obecabtagene Autoleucel (Obe-Cel, AUTO1) In Adults With
Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R
B-ALL): Overall Survival (OS), Event-Free Survival (EFS) And The
Potential Impact Of Chimeric Antigen Receptor (CAR)-T Cell
Persistency And Consolidative Stem Cell Transplantation (SCT) In
The Open-Label, Single-Arm FELIX Phase Ib/II Study |
Friday, May 313:57–4:09 p.m. CDT |
EHA Oral PresentationS114 |
Obecabtagene Autoleucel In Adult Relapsed/Refractory B Cell Acute
Lymphoblastic Leukemia: Survival And Potential Impact Of CAR-T Cell
Persistence And Stem Cell Transplantation In The FELIX Study |
Friday, June 143:45–4 p.m. CEST |
Multiple Myeloma |
ASCO Oral Presentation7505 |
Efficacy And Safety Of Ciltacabtagene Autoleucel ± Lenalidomide
Maintenance In Newly Diagnosed Multiple Myeloma With Suboptimal
Response To Frontline Autologous Stem Cell Transplant: CARTITUDE-2
Cohort D |
Monday, June 34:24–4:36 p.m. CDT |
EHA Oral PresentationS205 |
Ciltacabtagene Autoleucel ± Lenalidomide Maintenance In Newly
Diagnosed Multiple Myeloma With Suboptimal Response To Frontline
Autologous Stem Cell Transplant: CARTITUDE-2 Cohort D |
Saturday, June 154:30–4:45 p.m. CEST |
ASCO Oral Presentation7510 |
Efficacy Of Venetoclax-Dexamethasone (Vendex) V
Pomalidomide-Dexamethasone (Pomdex) In Patients (Pts) With
T(11;14)-Positive Relapsed/Refractory Multiple Myeloma [T(11;14)+
RRMM]: Phase 3 CANOVA Study Biomarker Subgroup Analysis |
Monday, June 34:24–4:36 p.m. CDT |
EHA Poster PresentationP912 |
Efficacy Of Venetoclax-Dexamethasone V Pomalidomide-Dexamethasone
In Patients With T(11;14)-Positive Relapsed/Refractory Multiple
Myeloma [T(11;14)+ RRMM]:Phase 3 CANOVA Biomarker Subgroup
Analysis |
Friday, June 146 p.m. CEST |
ASCO Oral Presentation7502 |
Daratumumab (DARA) + Bortezomib/Lenalidomide/Dexamethasone (VRd) In
Transplant-Eligible (TE) Patients (Pts) With Newly Diagnosed
Multiple Myeloma (NDMM): Analysis Of Minimal Residual Disease (MRD)
In the PERSEUS Trial |
Monday, June 33:24–3:36 p.m. CDT |
EHA Oral PresentationS201 |
Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in
Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma:
Analysis of Minimal Residual Disease in the PERSEUS Trial |
Saturday, June 1511:45 a.m.–12 p.m. CEST |
ASCO Oral Presentation7504 |
Ciltacabtagene Autoleucel Vs Standard of Care in Patients With
Functional High-Risk Multiple Myeloma: CARTITUDE-4 Subgroup
Analysis |
Monday, June 34:12–4:24 p.m. CDT |
EHA Poster PresentationP978 |
Ciltacabtagene Autoleucel Vs Standard of Care in
Lenalidomide-Refractory Multiple Myeloma: Phase 3 CARTITUDE-4
Subgroup Analysis By Cytogenetic Risk |
Friday, June 146 p.m. CEST |
Additional data to be presented at ASCO:
Presentation Type and Number |
Title |
Presentation Timing |
B-Cell Acute Lymphoblastic Leukemia |
Oral Presentation10014 |
Comparison Of Immunoglobulin High-Throughput Sequencing MRD in Bone
Marrow And Peripheral Blood In Pediatric B-ALL: A Report From The
Children's Oncology Group AALL1731 |
Monday, June 312:54–1:06 p.m. CDT |
Follicular Lymphoma |
Oral Presentation7015 |
EPCORE NHL1 Follicular Lymphoma (FL) Cycle (C) 1 Optimization (OPT)
Cohort: Expanding The Clinical Utility of Epcoritamab in Relapsed
o-r Refractory (R/R) FL |
Sunday, June 25:30–5:36 p.m. CDT |
Multiple Myeloma |
Oral Presentation106 |
Discontinuation of Maintenance Therapy in Multiple Myeloma Guided
By Multimodal Measurable Residual Disease Negativity
(MRD2STOP) |
Monday, June 310:01–10:13 a.m. CDT |
Oral Presentation7500 |
Phase 3 Study Results of Isatuximab, Bortezomib, Lenalidomide, And
Dexamethasone (Isa-Vrd) Versus Vrd For Transplant-Ineligible
Patients With Newly Diagnosed Multiple Myeloma (IMROZ) |
Monday, June 33–3:12 p.m. CDT |
Oral Presentation7501 |
Phase 3 Randomized Study of Isatuximab (Isa) Plus Lenalidomide And
Dexamethasone (Rd) With Bortezomib Versus Isard in Patients With
Newly Diagnosed Transplant Ineligible Multiple Myeloma (NDMM
TI) |
Monday, June 33:12–3:24 p.m. CDT |
Poster Presentation7527 |
Association Of Patient (Pt) Factors And Pharmacodynamic Biomarkers
With Progression-Free Survival (PFS) After Idecabtagene Vicleucel
(Ide-Cel) In Pts From KarMMa-3 |
Monday, June 39 a.m.–12 p.m. CDT |
Poster Presentation7535 |
Ciltacabtagene Autoleucel In Patients With Lenalidomide-Refractory
Multiple Myeloma: CARTITUDE-2 Cohort A Expansion Subgroup |
Monday, June 39 a.m.–12 p.m. CDT |
Poster Presentation7557 |
Effect Of Dose-Adjusted Melphalan On MRD-Negativity To Full Dose
Melphalan in Patients With Multiple Myeloma Post-Autologous Stem
Cell Transplant |
Monday, June 39 a.m.–12 p.m. CDT |
Poster Presentation7560 |
Indirect Comparison of Linvoseltamab Versus Teclistamab For
Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma
(RRMM) |
Monday, June 39 a.m.–12 p.m. CDT |
Additional data to be presented at EHA:
Presentation Type and Number |
Title |
Presentation Timing |
B-Cell Acute Lymphoblastic Leukemia |
Poster PresentationP413 |
Brexucabtagene Autoleucel (Brexu-Cel) As Consolidation Treatment in
Adults With B-Cell Acute Lymphoblastic Leukemia With Marrow Blasts
<5%, Including Patients (Pts) With NGS MRD Negative Disease |
Friday, June 146 p.m. CEST |
Chronic Lymphocytic Leukemia |
Oral PresentationS164 |
Combined Pirtobrutinib, Venetoclax, And Obinutuzumab in First-Line
Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): A
Phase 2 Trial |
Friday, June 143:45–4 p.m. CEST |
Poster Presentation P1837 |
Postinfusion Resource Use And Cost of Lisocabtagene Maraleucel By
Response Status And Prior Lines of Therapy In Patients With
Relapsed/Refractory Chronic Lymphocytic Leukemia From TRANSCEND CLL
004 |
Friday, June 146 p.m. CEST |
Poster PresentationP672 |
A Phase 2 Study of Minimal Residual Disease (MRD)-Adapted,
Time-Limited Acalabrutinib And Obinutuzumab For The Initial
Treatment of Patients With Chronic Lymphocytic Leukemia (CLL): MRD
Outcomes |
Friday, June 146 p.m. CEST |
Follicular Lymphoma |
Oral PresentationS234 |
Epcoritamab Induces Deep Responses in Relapsed Or Refractory (R/R)
Follicular Lymphoma (FL): Safety And Pooled Efficacy Data From
EPCORE NHL‑1 Pivotal And Cycle (C) 1 Optimization (OPT) FL
Cohorts |
Saturday, June 155:30–5:45 p.m. CEST |
Poster Presentation P1137 |
Undetectable Measurable Residual Disease (MRD) Is Associated With
Improved Long-Term Outcome in Patients With Follicular Lymphoma
(FL) Treated With Chemo-Immunotherapy: Results From SWOG S0016 |
Friday, June 146 p.m. CEST |
Poster PresentationP2059 |
Minimal Residual Disease (MRD), Pharmacokinetic (PK), And
Pharmacodynamic (PD) Assessment of Epcoritamab 2- Vs 3-Step Step-Up
Dosing in Patients With Relapsed/Refractory Follicular Lymphoma
(R/R FL) |
Friday, June 146 p.m. CEST |
Multiple Myeloma |
Poster Presentation P974 |
Daratumumab (DARA)/Bortezomib/Lenalidomide/Dexamethasone (D-VRd)
With D-R Maintenance (Maint) In Transplant-Eligible (TE) Newly
Diagnosed Myeloma (NDMM): Analysis of PERSEUS Based On Cytogenetic
Risk |
Friday, June 146 p.m. CEST |
Poster Presentation P943 |
Oral Ixazomib Maintenance Following Autologous Stem Cell Transplant
(ASCT) In Patients With Newly Diagnosed Multiple Myeloma (NDMM):
Final Overall Survival (OS) Analysis From The TOURMALINE-MM3
Study |
Friday, June 146 p.m. CEST |
About clonoSEQ
clonoSEQ is the first and only FDA-cleared in vitro diagnostic
(IVD) test service to detect minimal residual disease (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 diffuse large B-cell lymphoma (DLBCL) patients is currently
available for clinical use as a laboratory-developed test (LDT)
performed at Adaptive's CLIA-certified lab in Seattle, WA.
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.
About Adaptive BiotechnologiesAdaptive
Biotechnologies (“we” or “our”) 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. We apply our platform to partner
with biopharmaceutical companies, inform drug development, and
develop clinical diagnostics across our two business areas: Minimal
Residual Disease (MRD) and Immune Medicine. Our commercial products
and clinical pipeline enable the diagnosis, monitoring, and
treatment of diseases such as cancer, autoimmune disorders, and
infectious diseases. Our goal is to develop and commercialize
immune-driven clinical products tailored to each individual
patient.
Forward Looking Statements This press release
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including statements regarding our ability to develop,
commercialize and achieve market acceptance of our current and
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ADAPTIVE INVESTORSKarina Calzadilla, Vice
President, Investor
Relations201-396-1687investors@adaptivebiotech.com
ADAPTIVE MEDIAErica Jones, Associate Corporate
Communications Director206-279-2423media@adaptivebiotech.com
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