• Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Actionability of clonoSEQ® MRD Testing in Blood Cancer Patient Care and Drug Development at the 65th ASH Annual Meeting

    Источник: Nasdaq GlobeNewswire / 05 дек 2023 07:30:38   America/New_York

    SEATTLE, Dec. 05, 2023 (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 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.

    Key presentation details:

    AbstractTitle Presentation Timing
    Late-Breaking Abstract
    LBA-1Phase 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 TrialTuesday, December 12, 2023, 9:00 AM-10:30 AM
    Oral Presentations
    Chronic Lymphocytic Leukemia
    330Lisocabtagene Maraleucel (liso-cel) in R/R CLL/SLL: 24-Month Median Follow-up of TRANSCEND CLL 004Saturday, December 9, 2023: 5:15 PM
    634First-Line Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus Chlorambucil Plus Obinutuzumab (Clb+O): 55-Month Follow-up from the Glow StudySunday, December 10, 2023: 5:15 PM
    Diffuse Large B-Cell Lymphoma
    434Phase 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
    738A Multicenter Phase 2 Trial of Zanubrutinib, Obinutuzumab, and Venetoclax (BOVen) in Patients with Treatment-Naive, TP53-Mutant Mantle Cell LymphomaMonday, December 11, 2023: 11:45 AM
    1024Adaptive Manufacturing of LV20.19 CAR T-Cells for Relapsed, Refractory Mantle Cell LymphomaMonday, 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
    338Venetoclax 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 StudySaturday, December 9, 2023: 4:15 PM
    1028Idecabtagene 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-3Monday, December 11, 2023: 4:45 PM
    Poster Presentations
    AL Amyloidosis
    3398Using Next Generation Sequencing to Identify Trackable Clonotypic Sequences for Minimal Residual Disease Testing in AL AmyloidosisSunday, 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
    3257Multilayer Profiling of MRD in Patients with Relapsed/Refractory CLL Treated with Venetoclax-Based Regimens in a Real-World SettingSunday, 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 StudySunday, 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 StudySunday, December 10, 2023, 6:00 PM-8:00 PM
    Diffuse Large B-Cell Lymphoma
    5029Impact 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 ClonoSEQMonday, December 11, 2023, 6:00 PM-8:00 PM
    Follicular Lymphoma
    1655Epcoritamab 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 CohortSaturday, December 9, 2023, 5:30 PM-7:30 PM
    4359Minimal Residual Disease (MRD) Status Predicts Outcomes in Patients with Follicular Lymphoma (FL) Treated with Chemo-Immunotherapy on SWOG S0016Monday, December 11, 2023, 6:00 PM-8:00 PM
    Mantle Cell Lymphoma
    1673Post-CAR-T Minimal Residual Disease (MRD) Monitoring in Mantle Cell Lymphoma Enables Early Relapse DetectionSaturday, December 9, 2023, 5:30 PM-7:30 PM
    3036Acalabrutinib with Rituximab As First-Line Therapy for Older Patients with Mantle Cell Lymphoma – a Phase II Clinical TrialSunday, December 10, 2023, 6:00 PM-8:00 PM
    4407Minimal 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 StudyMonday, December 11, 2023, 6:00 PM-8:00 PM
    Multiple Myeloma
    1982Early 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
    2101Efficacy 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-upSaturday, 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 TherapySaturday, December 9, 2023, 5:30 PM-7:30 PM
    2339MRD Assessment in Patients with Newly Diagnosed Multiple Myeloma Using Tokenized Real World Data SourcesSaturday, December 9, 2023, 5:30 PM-7:30 PM
    3351Teclistamab Induces Favorable Responses in Patients with Relapsed and Refractory Multiple Myeloma after Prior BCMA-Directed TherapySunday, December 10, 2023, 6:00 PM-8:00 PM
    3380Primary 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
    3385Long-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
    3389Sequential T-Cell Engagement for Myeloma (“STEM”) Trial: A Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell TherapySunday, December 10, 2023, 6:00 PM-8:00 PM
    4671A 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
    4715Longitudinal 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
    4747Final 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 MyelomaSunday, 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 MalignanciesSunday, December 10, 2023, 6:00 PM-8:00 PM

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

    ADAPTIVE MEDIA
    Erica Jones, Associate Director, Corporate Communications
    206-279-2423
    media@adaptivebiotech.com


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