Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts on Utility of clonoSEQ® in MRD Testing in Blood Cancer Patients at the 63rd ASH Annual Meeting
Adaptive Biotechnologies (Nasdaq: ADPT) will present over 30 abstracts at the 63rd Annual Meeting of the American Society of Hematology (ASH) from December 11-14, showcasing the effectiveness of its clonoSEQ® Assay for assessing minimal residual disease (MRD) in blood cancer patients. This FDA-approved assay is significant for conditions like multiple myeloma and chronic lymphocytic leukemia. The data highlights clonoSEQ's role in guiding treatment decisions, aiding in precise disease monitoring, and improving patient outcomes. The event will feature several oral and poster presentations emphasizing these findings.
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SEATTLE, Dec. 02, 2021 (GLOBE NEWSWIRE) -- 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 utility of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay in assessing minimal residual disease (MRD) in blood cancer patients at the 63rd Annual Meeting of the American Society of Hematology (ASH), December 11-14.
clonoSEQ is the only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S.
“The data presented at ASH continues to build on evidence supporting the clinical value of serial MRD testing across blood cancers to help hematologists guide patient management, including the decision to stop treatment,” said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. “In both clinical trial and real-world settings, clonoSEQ has consistently demonstrated how NGS MRD assessment can meaningfully enhance the way patients and their clinicians understand and manage blood cancers.”
MRD assessment is a way to directly detect and quantify remaining disease during and after treatment. With clonoSEQ, clinicians can leverage a precise and reliable technique that can detect as little as one cancer cell among a million healthy cells with sufficient input material. This high sensitivity gives clinicians valuable insight into the dynamics of a patient’s disease, which can help predict outcomes, assess response, monitor remission, and detect potential relapse.
Data generated using clonoSEQ in its FDA-cleared indications and beyond will be featured in 9 oral presentations and 25 posters at ASH. The data to be presented demonstrate the utility of clonoSEQ for MRD-directed therapy, the value of sustained, deep MRD negativity, and the use of clonoSEQ to identify circulating tumor cells and circulating tumor DNA (ctDNA) in several lymphoma subtypes. The MRD-related data presented at ASH this year demonstrates how MRD-based decision-making is translating directly to improved patient care in blood cancers.
Earlier this month, Palmetto GBA’s Molecular Diagnostics Program (MolDX) finalized a local coverage determination (LCD) which supports Medicare coverage for clonoSEQ to detect and monitor MRD in patients with B-ALL, MM, and CLL. The LCD supports the potential expansion of coverage for additional clonoSEQ indications, providing a clear pathway for Non-Hodgkin Lymphoma (NHL) and other lymphoid cancers.
Key presentation details:
| Abstract | Title | Presentation Timing |
| Oral Presentations | ||
| Chronic Lymphocytic Leukemia | ||
| 70 | First Prospective Data on Minimal Residual Disease (MRD) Outcomes after Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of CLL in Elderly or Unfit Patients: The Glow Study | Saturday, December 11, 2021: 10:15 AM |
| 640 | Longer Term Follow-up of a Multicenter, Phase 2 Study of Ibrutinib Plus Fludarabine, Cyclophosphamide, Rituximab (iFCR) As Initial Therapy for Younger Patients with Chronic Lymphocytic Leukemia | Monday, December 13, 2021: 11:15 AM |
| Diffuse Large B-Cell Lymphoma | ||
| 52 | A Prospective Multicenter Study of Minimal Residual Disease Assessment Using a Next-Generation Immunosequencing Assay and CT Monitoring for Surveillance after Frontline Treatment in Diffuse Large B-Cell Lymphoma | Saturday, December 11, 2021: 10:15 AM |
| B-Cell Acute Lymphoblastic Leukemia | ||
| 274 | Diagnostic Utility of Multimodal Genomic Profiling for Molecular Classification and MRD Assessment in Adult B-Cell Acute Lymphoblastic Leukemia | Saturday, December 11, 2021: 2:45 PM |
| Non-Hodgkin Lymphoma | ||
| 95 | Phase 1/2 Trial of IL7/IL15-Expanded Bispecific LV20.19 CAR T-Cells for Relapsed, Refractory B-Cell Non-Hodgkin Lymphoma | Saturday, December 11, 2021: 10:30 AM |
| Multiple Myeloma | ||
| 79 | Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients (Pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of Griffin after 24 Months of Maintenance | Saturday, December 11, 2021: 9:30 AM |
| 481 | Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Transplantation and MRD Response-Adapted Consolidation and Treatment Cessation. Final Primary Endpoint Analysis of the Master Trial | Sunday, December 12, 2021: 12:00 PM |
| 483 | Biologic Basis of the Impact of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma Treated with Quadruplet Therapy | Sunday, December 12, 2021: 12:30 PM |
| 549 | Updated Results from CARTITUDE-1: Phase 1b/2Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients With Relapsed/Refractory Multiple Myeloma | Sunday, December 12, 2021: 5:00 PM |
| Poster Presentations | ||
| Acute Lymphoblastic Leukemia | ||
| 3485 | Performance of Next Generation Sequencing for Minimal Residual Disease Detection for Pediatric Patients with Acute Lymphoblastic Leukemia: Results from the Prospective Clinical Trial DFCI 16-001 | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| Chronic Lymphocytic Leukemia | ||
| 1553 | Majic: A Phase 3 Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Saturday, December, 11, 2021, 5:30 PM-7:30 PM |
| 3753 | Zanubrutinib, Obinutuzumab, and Venetoclax in Chronic Lymphocytic Leukemia: Early MRD Kinetics Define a High-Risk Patient Cohort with Delayed Bone Marrow Undetectable MRD and Earlier Post-Treatment MRD Recurrence | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3725 | Debulking before Initiation of Venetoclax Therapy in Untreated Patients with Chronic Lymphocytic Leukemia: Results from a Phase 3b Study | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3754 | Fixed Duration Combination Therapy with Ibrutinib (ibr) and Venetoclax (ven) Leads to Deep Responses in Relapsed/Refractory (rel/ref) Chronic Lymphocytic Leukemia (CLL): Results of a Phase 2 Study | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| Classical Hodgkin Lymphoma | ||
| 3491 | Prognostic Value of Minimal Residual Disease (MRD) Among Patients with Classical Hodgkin Lymphoma Undergoing Autologous Stem Cell Transplantation | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| Diffuse Large B-Cell Lymphoma | ||
| 1414 | High Grade B Cell Lymphoma with MYC and BCL2 and/or BCL6 Rearrangements Treated with DA-EPOCH-R Induction and Nivolumab Consolidation Treatment: Interim Results of the HOVON-152 Phase II Trial | Saturday, December 11, 2021, 5:30 PM-7:30 PM |
| Follicular Lymphoma | ||
| 1328 | A Prospective Study of Clonal Evolution in Follicular Lymphoma: Circulating Tumor DNA Correlates with Overall Tumor Burden and Fluctuates over Time without Therapy | Saturday, December 11, 2021, 5:30 PM-7:30 PM |
| 2397 | Concurrent Monitoring of Peripheral Blood Circulating Tumor DNA and Circulating Tumor Cells in Relapsed/Refractory Follicular Lymphoma Patients Post Axicabtagene Ciloleucel, a Single Center Experience | Sunday, December 12, 2021, 6:00 PM-8:00 PM |
| Mantle Cell Lymphoma | ||
| 2416 | Safety and Efficacy of Acalabrutinib Plus Venetoclax and Rituximab in Patients with Treatment-Naïve (TN) Mantle Cell Lymphoma (MCL) | Sunday, December 12, 2021, 6:00 PM-8:00 PM |
| 3530 | Safety and Efficacy of Ibrutinib Maintenance (I-M) Following Frontline Induction in Mantle Cell Lymphoma (MCL) with Sequential Assessment of Changes in NGS-MRD | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3537 | Phase 1b/2 Study of Vipor (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide) in Relapsed/Refractory and Untreated Mantle Cell Lymphoma: Safety, Efficacy, and Molecular Analysis | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| Multiple Myeloma | ||
| 1625 | Retrospective Analysis of Minimal Residual Disease Testing By High Throughput Immunosequencing Versus High Sensitivity Flow Cytometry in Multiple Myeloma | Saturday, December 11, 2021, 5:30 PM-7:30 PM |
| 1648 | Progression-Free Survival Outcomes By Response Status for Bortezomib, Melphalan, and Prednisone with or without Daratumumab in Newly Diagnosed Multiple Myeloma: Pooled Subgroup Analysis of Octans and Alcyone | Saturday, December 11, 2021, 5:30 PM-7:30 PM |
| 1739 | Baseline Correlates of Complete Response to Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy in Patients with Relapsed and Refractory Multiple Myeloma: Subanalysis of the KarMMa Trial | Saturday, December 11, 2021, 5:30 PM-7:30 PM |
| 2723 | Daratumumab Plus Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) in Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts): A Subgroup Analysis of Griffin | Sunday, December 12, 2021, 6:00 PM-8:00 PM |
| 2759 | A Phase 2 Study of Extended Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma | Sunday, December 12, 2021, 6:00 PM-8:00 PM |
| 2910 | CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T-Cell Therapy, in Patients with Multiple Myeloma and Early Relapse after Initial Therapy | Sunday, December 12, 2021, 6:00 PM-8:00 PM |
| 3783 | Longitudinal MRD Assessment in Real-World Multiple Myeloma Patients Using Next-Generation Sequencing (clonoSEQ® Assay) | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3806 | Response Kinetics of Daratumumab-Based Regimens in Patients with Newly Diagnosed or Refractory/Relapsed Multiple Myeloma | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3832 | Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and /or Refractory Multiple Myeloma | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3866 | Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-Cell Maturation Antigen (BCMA)–Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Lenalidomide-Refractory Patients with Progressive Multiple Myeloma after 1–3 Prior Lines of Therapy: Updated Results from CARTITUDE-2 | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3938 | Efficacy and Safety of Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 Subgroup Analysis | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3946 | Prospective Comparison Study of Prognostic Value of MRD Detected By 8-Color MFC (EuroFlow-NGF) and NGS in Patients with Multiple Myeloma in ASCT Setting | Monday, December 13, 2021, 6:00 PM-8:00 PM |
| 3950 | Comparison of MRD Detection in Autografts in Multiple Myeloma between Novel High-Sensitivity Euroflow-NGF and NGS | Monday, December 13, 2021, 6:00 PM-8:00 PM |
About the clonoSEQ Assay
The 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 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 MRD assessment in other lymphoid cancers and sample types, as well as for determination of IGHV mutation status in CLL/SLL patients. 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 Biotechnologies
Adaptive 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
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ADAPTIVE MEDIA
Erica Schmitt
206-279-2423
media@adaptivebiotech.com
ADAPTIVE INVESTORS
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
investors@adaptivebiotech.com
FAQ
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