• Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Clinical Utility and Benefit of clonoSEQ® MRD Testing in Blood Cancer Patients at 2022 ASH Annual Meeting

    来源: Nasdaq GlobeNewswire / 05 12月 2022 06:30:00   America/Chicago

    SEATTLE, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), together with its collaborators, will present data from more than 30 abstracts showcasing the benefit of Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay in measuring minimal residual disease (MRD) in blood cancer patients at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10-13, 2022.

    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). Adaptive recently announced the launch of clonoSEQ to assess MRD in the blood of patients with diffuse large B-cell lymphoma (DLBCL) using ctDNA. The assay is widely available to clinicians and patients across the U.S.

    “The data presented at ASH continues to reinforce the value of serial MRD testing with clonoSEQ as a sensitive prognostic tool in real-world settings and in clinical trials,” said Nitin Sood, chief commercial officer, MRD, Adaptive Biotechnologies. “Data continues to demonstrate that testing MRD at multiple timepoints throughout a patient’s cancer journey is part of the new standard of care for most lymphoid malignancies and is critical to a physician’s ability to assess prognosis, determine response to treatment, detect relapse, and ultimately optimize care.”

    MRD testing allows for direct measurement of the number of cancer cells remaining in the body during and after treatment. Leveraging Adaptive’s immune medicine platform, clonoSEQ can detect one cancer cell among a million healthy cells. Assessment with clonoSEQ provides a standardized, accurate, and sensitive measurement of MRD.

    Data generated using clonoSEQ across various blood cancers will be featured in the selected 12 oral presentations and 21 posters listed below at ASH. Five of the presentations are studies using real-world evidence to demonstrate how serial clonoSEQ testing is being utilized in the clinic to inform physician decisions across indications and therapeutic regimens to guide personalized treatment plans, including discontinuation of therapy. Other presentations will highlight the value of utilizing clonoSEQ in clinical trials to assess and predict the effectiveness of investigational, novel therapeutics.

    Key presentation details:

    AbstractTitle Presentation Timing
    Oral Presentations
    Multiple Myeloma
    158Elranatamab, a BCMA Targeted T-Cell Engaging Bispecific Antibody, Induces Durable Clinical and Molecular Responses for Patients with Relapsed or Refractory Multiple MyelomaSaturday, December 10, 2022: 12:15 PM
    361KarMMa-2 Cohort 2a: Efficacy and Safety of Idecabtagene Vicleucel in Clinical High-Risk Multiple Myeloma Patients with Early Relapse after Frontline Autologous Stem Cell TransplantationSaturday, December 10, 2022: 4:00 PM
    565Final Results from the First-in-Human Phase 1/2 Study of Modakafusp Alfa, an Immune-Targeting Attenuated Cytokine, in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)Sunday, December 11, 2022: 12:00 PM
    868Early and Sustained Undetectable Measurable Residual Disease (MRD) after Idecabtagene Vicleucel (ide-cel) Defines a Subset of Multiple Myeloma (MM) Patients in Karmma Achieving Prolonged SurvivalMonday, December 12, 2022: 3:30 PM
    870Prospective Trial Using Multimodal Measurable Residual Disease Negativity to Guide Discontinuation of Maintenance Therapy in Multiple Myeloma (MRD2STOP)Monday, December 12, 2022: 4:00 PM
    Chronic Lymphocytic Leukemia
    93Residual Disease Kinetics Among Patients with High-Risk Factors Treated with First-Line Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus Chlorambucil Plus Obinutuzumab (Clb+O): The Glow StudySaturday, December 10, 2022: 10:00 AM
    344Updated Results from a Multicenter, Phase 2 Study of Acalabrutinib, Venetoclax, Obinutuzumab (AVO) in a Population of Previously Untreated Patients with CLL Enriched for High-Risk DiseaseSaturday, December 10, 2022: 4:15 PM
    Acute Lymphoblastic Leukemia
    213Ponatinib and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Subgroup Analysis from a Phase II StudySaturday, December 10, 2022: 2:30 PM
    720Ultra-Sensitive Next-Generation Sequencing Establishes the Prognostic Value of Very Low MRD in Adults with Acute Lymphoblastic Leukemia Undergoing Hematopoietic Cell TransplantationMonday, December 12, 2022: 11:45 AM
    Mantle Cell Lymphoma
    73Phase 2 Trial of Acalabrutinib-Lenalidomide-Rituximab (ALR) with Real-Time Monitoring of MRD in Patients with Treatment-Naïve Mantle Cell LymphomaSaturday, December 10, 2022: 9:30 AM
    75Time-Limited Ibrutinib and Tisagenlecleucel Is Highly Effective in the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma, Including Those with TP53 Mutated and Btki-Refractory Disease: First Report of the Tarmac StudySaturday, December 10, 2022: 10:00 AM
    Follicular Lymphoma
    952Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide (ViPOR) in Relapsed and Refractory Follicular Lymphoma: Analysis of Safety, Efficacy, and Minimal Residual DiseaseMonday, December 12, 2022: 5:15 PM
    Poster Presentations
    Multiple Blood Cancers
    2275Interim Update on the ‘Watch’ Registry, a Real-World Observational Study Using Clonoseq® to Monitor MRD in Lymphoid MalignanciesSaturday, December 10, 2022, 5:30 PM-7:30 PM

    4816Utility of High-Throughput Sequencing of Immunoglobulin Genes for MRD in Lymphoid Malignancy in the Context of Current ImmunotherapeuticsMonday, December 12, 2022: 6:00 PM-8:00 PM
    Acute Lymphoblastic Leukemia
    2729
    		A Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy (mini-hyper-CVD) and Ponatinib Followed By Blinatumomab and Ponatinib in Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)Sunday, December 11, 2022, 6:00 PM-8:00 PM

    Diffuse Large B-Cell Lymphoma
    4251Epcoritamab Monotherapy Provides Deep and Durable Responses Including Minimal Residual Disease (MRD) Negativity: Novel Subgroup Analyses in Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)Monday, December 12, 2022: 6:00 PM-8:00 PM

    Mantle Cell Lymphoma
    2884Acalabrutinib Plus Venetoclax and Rituximab in Patients with Treatment-Naïve (TN) Mantle Cell Lymphoma (MCL): 2-Year Safety and Efficacy AnalysisSaturday, December 10, 2022, 5:30 PM-7:30 PM
    4806Immunoglobulin High Throughput Sequencing (Ig-HTS) Minimal Residual Disease (MRD) Analysis Is an Effective Surveillance Tool in Patients with Mantle Cell LymphomaMonday, December 12, 2022: 6:00 PM-8:00 PM

    Multiple Myeloma
    3218A Real-World Study on the Feasibility of Minimal Residual Disease Testing By Next-Generation Sequencing in Systemic Light-Chain AmyloidosisSaturday, December 10, 2022, 5:30 PM-7:30 PM

    1934Interim Results of a Risk-Adaptive Phase II Study: Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab (KRD-Dara) in Newly Diagnosed Multiple Myeloma (NDMM) at the Levine Cancer Institute (LCI)Saturday, December 10, 2022, 5:30 PM-7:30 PM

    1930Quadruplet Induction, Autologous Transplantation and Minimal Residual Disease Adapted Consolidation and Treatment Cessation in Older Adults ≥70y with Newly Diagnosed Multiple Myeloma: A Subgroup Analysis of the Master TrialSaturday, December 10, 2022, 5:30 PM-7:30 PM

    3237Outcomes of MRD-Adapted Treatment Modulation in Patients with Newly Diagnosed Multiple Myeloma Receiving Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd) and Autologous Transplantation: Extended Follow up of the Master TrialSaturday, December 10, 2022, 5:30 PM-7:30 PM

    3239A Phase II Study of Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, and Isatuximab in Newly Diagnosed, Transplant-Eligible Multiple Myeloma (The SKylaRk Trial)Saturday, December 10, 2022, 5:30 PM-7:30 PM

    3314KarMMa-2 Cohort 2c: Efficacy and Safety of Idecabtagene Vicleucel in Patients with Clinical High-Risk Multiple Myeloma Due to Inadequate Response to Frontline Autologous Stem Cell TransplantationSaturday, December 10, 2022, 5:30 PM-7:30 PM

    3313Phase 1 Study of CART-Ddbcma for the Treatment of Subjects with Relapsed and /or Refractory Multiple MyelomaSaturday, December 10, 2022, 5:30 PM-7:30 PM
    3354
    		Ciltacabtagene Autoleucel (Cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients with Multiple Myeloma (MM) and Early Relapse after Initial Therapy: CARTITUDE-2 Cohort B 18-Month Follow-upSaturday, December 10, 2022, 5:30 PM-7:30 PM

    2030Efficacy Outcomes and Characteristics of Patients with Multiple Myeloma (MM) Who Achieved Sustained Minimal Residual Disease Negativity after Treatment with Ciltacabtagene Autoleucel (cilta-cel) in CARTITUDE-1Saturday, December 10, 2022, 5:30 PM-7:30 PM

    3593Induction Quadruplet Therapy and Minimal/Measurable Residual Disease (MRD)-Informed Treatment Adaptation in Newly Diagnosed Multiple Myeloma (NDMM): Results from an Academic-Community PathwaySaturday, December 10, 2022, 5:30 PM-7:30 PM

    4466Needle in a Haystack: A Pilot Study Combining Single-Cell Multiomics with Clinical NGS-MRD Sequencing to Search for Circulating Clonotypic Dedifferentiated Myeloma CellsMonday, December 12, 2022: 6:00 PM-8:00 PM

    4527Humoral Immune Reconstitution Following Therapy with Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Hematopoietic Cell Transplantation (AHCT) and MRD-Response-Adapted Treatment CessationMonday, December 12, 2022: 6:00 PM-8:00 PM

    4553Daratumumab Plus Lenalidomide and Dexamethasone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Maia Age Subgroup AnalysisMonday, December 12, 2022: 6:00 PM-8:00 PM

    4559Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of the Phase 3 Maia StudyMonday, December 12, 2022: 6:00 PM-8:00 PM

    4561Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) Alone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of the Phase 3 Alcyone StudyMonday, December 12, 2022: 6:00 PM-8:00 PM

    About the clonoSEQ Assay
    The clonoSEQ Assay 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 ctDNA-based MRD testing in DLBCL has also been approved by New York State's Clinical Laboratory Evaluation Program (CLEP). Medicare covers clonoSEQ in these four indications and is aligned with clinical practice guidelines which support assessing MRD at multiple time points throughout therapy to monitor treatment response and help predict patient outcomes.

    The clonoSEQ Assay 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 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, 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 Biotechnologies
    Adaptive 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 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 the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and 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.

    ADAPTIVE MEDIA
    Mary Pat Lancelotta
    206-600-6702
    media@adaptivebiotech.com

    ADAPTIVE INVESTORS
    Karina Calzadilla, Vice President, Investor Relations
    201-396-1687
    investors@adaptivebiotech.com


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