- Studies reinforce clonoSEQ as standard of care in minimal residual disease (MRD) across eight disease states
- Real-world evidence shows treatment decisions based on precise MRD measurement directly correlate with improved patient outcomes and cost savings
SEATTLE, Nov. 23, 2020 (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 35 abstracts studying the use of Adaptive’s clonoSEQ® Assay for minimal residual disease (MRD) assessment at the American Society of Hematology (ASH) virtual 62nd Annual Meeting and Exposition, December 5-8. clonoSEQ is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for MRD assessment in chronic lymphocytic leukemia (CLL), multiple myeloma and B-cell acute lymphoblastic leukemia (B-ALL) and is widely available to clinicians and patients across the U.S.
“We are thrilled to see so many investigators presenting clonoSEQ data at ASH this year, among the more than 300 ASH studies highlighting MRD data, significantly growing the body of evidence validating this tool as a critical measure of patient outcomes,” said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. “As innovation continues for the treatment of blood cancers with novel and highly targeted therapies that create deep and durable responses for patients, we see clinicians increasingly utilizing clonoSEQ to help guide day-to-day patient care.”
Assessment of MRD is a way to directly detect and quantify remaining disease, even in the absence of symptoms, across a spectrum of blood cancers. A patient’s MRD status gives clinicians timely information about how a patient may be responding to treatment, so patients and providers can be in control when it comes to managing their disease and treatment decisions.
clonoSEQ, the first clinical application of Adaptive’s immune medicine platform, will be featured in 14 oral presentations and 23 posters at ASH. Data on clinical and research utility from studies, as well as findings based on real-world experience, will be presented across a range of cancers including multiple myeloma, ALL, CLL and non-Hodgkin’s lymphoma (NHL). These new data show a correlation between clonoSEQ MRD results and improved blood cancer patient outcomes, enhanced clinical decision-making, and potential savings to the healthcare system.
Additional data at ASH this year will highlight Adaptive’s immune profiling research tool, immunoSEQ®, to quantitatively assess the immune response to novel therapies in development.
Key presentations include:
|Abstract ||Title ||Presentation |
|Acute Lymphoblastic Leukemia|
|583||Ultrasensitive Next-Generation Sequencing-Based Measurable Residual Disease Assessment in Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia after Frontline Therapy: Correlation with Flow Cytometry and Impact on Clinical Outcomes||Monday, December 7, 2020: 9:15 AM|
|Chronic Lymphocytic Leukemia|
|127||Clonal Dynamics after Venetoclax-Obinutuzumab Therapy: Novel Insights from the Randomized, Phase 3 CLL14 Trial||Saturday, December 5, 2020: 10:30 AM|
|544||Transcend CLL 004: Phase 1 Cohort of Lisocabtagene Maraleucel (liso-cel) in Combination with Ibrutinib for Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)||Monday, December 7, 2020: 7:30 AM|
|546||Updated Follow-up of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated with Lisocabtagene Maraleucel in the Phase 1 Monotherapy Cohort of Transcend CLL 004, Including High-Risk and Ibrutinib-Treated Patients||Monday, December 7, 2020: 8:00 AM|
|Diffuse Large B-Cell Lymphoma|
|531||Prognostic Value of Circulating Tumor DNA (ctDNA) in Autologous Stem Cell Graft and Post-Transplant Plasma Samples Among Patients with Diffuse Large B-Cell Lymphoma||Monday, December 7, 2020: 7:15 AM|
|730||TCR Repertoires in Graft-Versus-Host-Disease (GVHD)-Target Tissues Reveals Tissue Specificity of the Alloimmune Response||Monday, December 7, 2020: 1:30 PM|
|530||Cerebrospinal Fluid (CSF) Analysis of Tumor-Specific Cell-Free DNA (cfDNA) As a Diagnostic and Prognostic Tool for Central Nervous System (CNS) Invasion in Lymphoma||Monday, December 7, 2020: 7:00 AM|
|Mantle Cell Lymphoma|
|119||Frontline Sequential Immunochemotherapy Plus Lenalidomide for Mantle Cell Lymphoma Incorporating MRD Evaluation: Phase II, Investigator-Initiated, Single-Center Study||Saturday, December 5, 2020: 10:00 AM|
|Multiple Myeloma |
|143||Early Versus Late Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma: Long-Term Follow-up Analysis of the IFM 2009 Trial||Saturday, December 5, 2020: 10:00 AM|
|722||Spatiotemporal Assessment of Immunogenomic Heterogeneity in Multiple Myeloma||Monday, December 7, 2020: 2:15 PM|
|Acute Lymphoblastic Leukemia|
|975||Monitoring Measurable Residual Disease Using Peripheral Blood in Acute Lymphoblastic Leukemia: Results of a Prospective, Observational Study||Saturday, December 5, 2020, 7:00 AM-3:30 PM|
|Cutaneous T-Cell Lymphoma|
|2082||Patient Characteristics of Long-Term Responders to Mogamulizumab: Results from the MAVORIC Study||Sunday, December 6, 2020, 7:00 AM-3:30 PM|
|Diffuse Large B-Cell Lymphoma|
|1450||Blinatumomab Consolidation Post Autologous Hematopoietic Stem Cell Transplantation in Patients with Diffuse Large B Cell Lymphoma||Saturday, December 5, 2020, 7:00 AM-3:30 PM|
|Mantle Cell Lymphoma|
|3031||Ibrutinib Maintenance (I-M) Following Intensive Induction in Mantle Cell Lymphoma (MCL): Efficacy, Safety and Changes in Minimal Residual Disease||Monday, December 7, 2020, 7:00 AM-3:30 PM|
|1328||Improving the Definition of Response Assessment: Prognostic Value of Minimal Residual Disease Combined with PET/CT at Day 100 Post Autologous Stem Cell Transplantation in Multiple Myeloma||Saturday, December 5, 2020, 7:00 AM-3:30 PM|
|1592||Role of clonoSEQ®, a Next-Generation Sequencing (NGS) Assay and PET/CT As a Measure of Minimal Residual Disease Negativity Among Patients with Multiple Myeloma||Saturday, December 5, 2020, 7:00 AM-3:30 PM|
|2237||Making Clinical Decisions to Change Therapy Using Measurable Residual Disease Improves the Outcome in Multiple Myeloma||Sunday, December 6, 2020, 7:00 AM-3:30 PM|
|3426||Cost-Effectiveness of Implementing Clonoseq NGS-MRD Testing Using the Emory MRD Decision Protocol in Multiple Myeloma||Monday, December 7, 2020, 7:00 AM-3:30 PM|
|3156||Minimal Residual Disease in Multiple Myeloma: Targeted Mass Spectrometry in Blood Vs Next Generation Sequencing in Bone Marrow||Monday, December 7, 2020, 7:00 AM-3:30 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 B-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 use in other lymphoid cancers and sample types. 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 immunoSEQ Assay
Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, the immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures.
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 two 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.
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Carrie Mendivil, Gilmartin Group
Source: Adaptive Biotechnologies
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