• 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

    Источник: Nasdaq GlobeNewswire / 02 дек 2021 08:00:01   America/New_York

    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:

    AbstractTitle 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 StudySaturday, 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 LeukemiaMonday, 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 LymphomaSaturday, December 11, 2021: 10:15 AM
    B-Cell Acute Lymphoblastic Leukemia
    274Diagnostic Utility of Multimodal Genomic Profiling for Molecular Classification and MRD Assessment in Adult B-Cell Acute Lymphoblastic LeukemiaSaturday, December 11, 2021: 2:45 PM
    Non-Hodgkin Lymphoma
    95Phase 1/2 Trial of IL7/IL15-Expanded Bispecific LV20.19 CAR T-Cells for Relapsed, Refractory B-Cell Non-Hodgkin LymphomaSaturday, 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 MaintenanceSaturday, 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 TrialSunday, December 12, 2021: 12:00 PM
    483
    		Biologic Basis of the Impact of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma Treated with Quadruplet TherapySunday, 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 MyelomaSunday, 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 16-001Monday, 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 LymphomaSaturday, 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 RecurrenceMonday, 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 StudyMonday, 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 StudyMonday, 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 TransplantationMonday, 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 TrialSaturday, 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 TherapySaturday, 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 ExperienceSunday, 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-MRDMonday, 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 AnalysisMonday, 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 MyelomaSaturday, 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 AlcyoneSaturday, 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 TrialSaturday, 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 GriffinSunday, 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 MyelomaSunday, 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 TherapySunday, 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 MyelomaMonday, 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 MyelomaMonday, 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-2Monday, 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 AnalysisMonday, 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 SettingMonday, 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 NGSMonday, 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
    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.

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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


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