GlobeNewswire Inc | Dec 2, 2021 08:00AM EST

December 02, 2021

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 Adaptives 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 patients 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 GBAs 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 TimingOral PresentationsChronic Lymphocytic Leukemia First Prospective Data on Minimal Residual Disease (MRD) Outcomes after Fixed-Duration Ibrutinib Plus Saturday,70 Venetoclax (Ibr+Ven) Versus Chlorambucil Plus December 11, Obinutuzumab (Clb+O) for First-Line Treatment of CLL in 2021: 10:15 AM Elderly or Unfit Patients: The Glow Study Longer Term Follow-up of a Multicenter, Phase 2 Study Monday,640 of Ibrutinib Plus Fludarabine, Cyclophosphamide, December 13, Rituximab (iFCR) As Initial Therapy for Younger 2021: 11:15 AM Patients with Chronic Lymphocytic LeukemiaDiffuse Large B-Cell Lymphoma A Prospective Multicenter Study of Minimal Residual Disease Assessment Using a Next-Generation Saturday,52 Immunosequencing Assay and CT Monitoring for December 11, Surveillance after Frontline Treatment in Diffuse Large 2021: 10:15 AM B-Cell LymphomaB-Cell Acute Lymphoblastic Leukemia Diagnostic Utility of Multimodal Genomic Profiling for Saturday,274 Molecular Classification and MRD Assessment in Adult December 11, B-Cell Acute Lymphoblastic Leukemia 2021: 2:45 PMNon-Hodgkin Lymphoma Phase 1/2 Trial of IL7/IL15-Expanded Bispecific LV20.19 Saturday,95 CAR T-Cells for Relapsed, Refractory B-Cell Non-Hodgkin December 11, Lymphoma 2021: 10:30 AMMultiple Myeloma Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients (Pts) with Saturday,79 Transplant-Eligible Newly Diagnosed Multiple Myeloma December 11, (NDMM): Updated Analysis of Griffin after 24 Months of 2021: 9:30 AM Maintenance Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd), Autologous Transplantation Sunday,481 and MRD Response-Adapted Consolidation and Treatment December 12, Cessation. Final Primary Endpoint Analysis of the 2021: 12:00 PM Master Trial Biologic Basis of the Impact of Autologous Sunday,483 Hematopoietic Cell Transplantation in Multiple Myeloma December 12, Treated with Quadruplet Therapy 2021: 12:30 PM Updated Results from CARTITUDE-1: Phase 1b/2Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Sunday,549 Antigen?Directed Chimeric Antigen Receptor T Cell December 12, Therapy, in Patients With Relapsed/Refractory Multiple 2021: 5:00 PM MyelomaPoster PresentationsAcute Lymphoblastic Leukemia Performance of Next Generation Sequencing for Minimal Monday,3485 Residual Disease Detection for Pediatric Patients with December 13, Acute Lymphoblastic Leukemia: Results from the 2021, 6:00 Prospective Clinical Trial DFCI 16-001 PM-8:00 PMChronic Lymphocytic Leukemia Majic: A Phase 3 Prospective, Multicenter, Randomized, Saturday, Open-Label Trial of Acalabrutinib Plus Venetoclax December, 11,1553 Versus Venetoclax Plus Obinutuzumab in Previously 2021, 5:30 Untreated Chronic Lymphocytic Leukemia or Small PM-7:30 PM Lymphocytic Lymphoma Zanubrutinib, Obinutuzumab, and Venetoclax in Chronic Monday, Lymphocytic Leukemia: Early MRD Kinetics Define a December 13,3753 High-Risk Patient Cohort with Delayed Bone Marrow 2021, 6:00 Undetectable MRD and Earlier Post-Treatment MRD PM-8:00 PM Recurrence Debulking before Initiation of Venetoclax Therapy in Monday,3725 Untreated Patients with Chronic Lymphocytic Leukemia: December 13, Results from a Phase 3b Study 2021, 6:00 PM-8:00 PM Fixed Duration Combination Therapy with Ibrutinib (ibr) Monday,3754 and Venetoclax (ven) Leads to Deep Responses in December 13, Relapsed/Refractory (rel/ref) Chronic Lymphocytic 2021, 6:00 Leukemia (CLL): Results of a Phase 2 Study PM-8:00 PMClassical Hodgkin Lymphoma Prognostic Value of Minimal Residual Disease (MRD) Monday,3491 Among Patients with Classical Hodgkin Lymphoma December 13, Undergoing Autologous Stem Cell Transplantation 2021, 6:00 PM-8:00 PMDiffuse Large B-Cell Lymphoma High Grade B Cell Lymphoma with MYC and BCL2 and/or Saturday,1414 BCL6 Rearrangements Treated with DA-EPOCH-R Induction December 11, and Nivolumab Consolidation Treatment: Interim Results 2021, 5:30 of the HOVON-152 Phase II Trial PM-7:30 PMFollicular Lymphoma A Prospective Study of Clonal Evolution in Follicular Saturday,1328 Lymphoma: Circulating Tumor DNA Correlates with Overall December 11, Tumor Burden and Fluctuates over Time without Therapy 2021, 5:30 PM-7:30 PM Concurrent Monitoring of Peripheral Blood Circulating Sunday,2397 Tumor DNA and Circulating Tumor Cells in Relapsed/ December 12, Refractory Follicular Lymphoma Patients Post 2021, 6:00 Axicabtagene Ciloleucel, a Single Center Experience PM-8:00 PMMantle Cell Lymphoma Safety and Efficacy of Acalabrutinib Plus Venetoclax Sunday,2416 and Rituximab in Patients with Treatment-Nave (TN) December 12, Mantle Cell Lymphoma (MCL) 2021, 6:00 PM-8:00 PM Safety and Efficacy of Ibrutinib Maintenance (I-M) Monday,3530 Following Frontline Induction in Mantle Cell Lymphoma December 13, (MCL) with Sequential Assessment of Changes in NGS-MRD 2021, 6:00 PM-8:00 PM Phase 1b/2 Study of Vipor (Venetoclax, Ibrutinib, Monday,3537 Prednisone, Obinutuzumab, and Lenalidomide) in Relapsed December 13, /Refractory and Untreated Mantle Cell Lymphoma: Safety, 2021, 6:00 Efficacy, and Molecular Analysis PM-8:00 PMMultiple Myeloma Retrospective Analysis of Minimal Residual Disease Saturday,1625 Testing By High Throughput Immunosequencing Versus High December 11, Sensitivity Flow Cytometry in Multiple Myeloma 2021, 5:30 PM-7:30 PM Progression-Free Survival Outcomes By Response Status Saturday,1648 for Bortezomib, Melphalan, and Prednisone with or December 11, without Daratumumab in Newly Diagnosed Multiple 2021, 5:30 Myeloma: Pooled Subgroup Analysis of Octans and Alcyone PM-7:30 PM Baseline Correlates of Complete Response to Saturday, Idecabtagene Vicleucel (ide-cel, bb2121), a December 11,1739 BCMA-Directed CAR T Cell Therapy in Patients with 2021, 5:30 Relapsed and Refractory Multiple Myeloma: Subanalysis PM-7:30 PM of the KarMMa Trial Daratumumab Plus Lenalidomide, Bortezomib, and Sunday,2723 Dexamethasone (D-RVd) in Transplant-Eligible Newly December 12, Diagnosed Multiple Myeloma (NDMM) Patients (Pts): A 2021, 6:00 Subgroup Analysis of Griffin PM-8:00 PM A Phase 2 Study of Extended Daratumumab, Carfilzomib, Sunday,2759 Lenalidomide, and Dexamethasone in Newly Diagnosed December 12, Multiple Myeloma 2021, 6:00 PM-8:00 PM CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Sunday, Autoleucel, a B-Cell Maturation Antigen (BCMA)-Directed December 12,2910 Chimeric Antigen Receptor T-Cell Therapy, in Patients 2021, 6:00 with Multiple Myeloma and Early Relapse after Initial PM-8:00 PM Therapy Longitudinal MRD Assessment in Real-World Multiple Monday,3783 Myeloma Patients Using Next-Generation Sequencing December 13, (clonoSEQ Assay) 2021, 6:00 PM-8:00 PM Response Kinetics of Daratumumab-Based Regimens in Monday,3806 Patients with Newly Diagnosed or Refractory/Relapsed December 13, Multiple Myeloma 2021, 6:00 PM-8:00 PM Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing Monday,3832 a Novel Synthetic Binding Domain for the Treatment of December 13, Subjects with Relapsed and /or Refractory Multiple 2021, 6:00 Myeloma PM-8:00 PM Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-Cell Maturation Antigen (BCMA) Monday,3866 ?Directed Chimeric Antigen Receptor (CAR) T-Cell December 13, Therapy, in Lenalidomide-Refractory Patients with 2021, 6:00 Progressive Multiple Myeloma after 1?3 Prior Lines of PM-8:00 PM Therapy: Updated Results from CARTITUDE-2 Efficacy and Safety of Ciltacabtagene Autoleucel in Monday,3938 Patients With Relapsed/Refractory Multiple Myeloma: December 13, CARTITUDE-1 Subgroup Analysis 2021, 6:00 PM-8:00 PM Prospective Comparison Study of Prognostic Value of MRD Monday,3946 Detected By 8-Color MFC (EuroFlow-NGF) and NGS in December 13, Patients with Multiple Myeloma in ASCT Setting 2021, 6:00 PM-8:00 PM Comparison of MRD Detection in Autografts in Multiple Monday,3950 Myeloma between Novel High-Sensitivity Euroflow-NGF and December 13, NGS 2021, 6:00 PM-8:00 PM

About the clonoSEQ AssayThe 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 Adaptives 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 visitwww.clonoSEQ.com/technical-summary.

About Adaptive BiotechnologiesAdaptive Biotechnologiesis 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 natures 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 visitadaptivebiotech.comand follow us onwww.twitter.com/adaptivebiotech.

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ADAPTIVE MEDIAErica Schmitt206-279-2423media@adaptivebiotech.com

ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687Carrie Mendivil, Gilmartin Groupinvestors@adaptivebiotech.com