U.S. Markets open in 8 hrs 18 mins

Adaptive Biotechnologies and Collaborators to Present Data from More Than 25 clonoSEQ® Abstracts at ASH 2019 Demonstrating Clinical Relevance of Standardized, Accurate MRD Testing for Blood Cancer Patients

Research and real-world evidence support the use across a range of leukemias and lymphomas and demonstrate utility in multiple tissue types, including blood and bone marrow

Late breaker presentation of CANDOR study includes secondary endpoint of improved NGS MRD negative Complete Response Rate at 12 months

SEATTLE, Dec. 04, 2019 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (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, and its collaborators will present data from more than 25 abstracts for Adaptive’s next-generation sequencing (NGS)-based clonoSEQ Assay at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL, December 7 - 10. clonoSEQ is the only FDA-cleared test to monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples.

“An unprecedented amount of MRD data are being presented at the ASH annual meeting, demonstrating its established significance as a clinical trial endpoint and a validated measure of patient outcomes in select blood cancers,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “The widespread use of clonoSEQ in clinical research and in patient care underscores the need for a highly sensitive, standardized test that gives patients, clinicians and drug developers confidence in their assessment of MRD status.”

MRD is a measure of the amount of cancer in the body, specifically the very small number of cancer cells that remain during or after treatment. MRD testing is performed as a series of tests throughout a patient’s cancer journey to regularly inform treatment decisions. In addition to routine use of MRD as a key endpoint to measure response in research, MRD is being used as an endpoint in clinical trials, and now it is rapidly being incorporated into clinical practice. As MRD measurement continues to inform day-to-day clinical practice, real-world data mounts confirming the outcomes in established in research which includes the ability to assess prognosis, evaluate depth of response to therapy and monitor disease burden over time.

clonoSEQ, the first clinical application of Adaptive’s immune medicine platform, will be featured in a late-breaker presentation, 9 oral presentations and more than 15 posters. Data on approved, investigational and research uses from studies and real-world experience will be presented across a range of cancers including multiple myeloma, ALL, CLL, and NHLs such as DLBCL, FL and MCL. These new data support the use of NGS MRD testing in multiple disease settings using both bone marrow and blood samples, as well as the important role of MRD monitoring in a real-world clinical setting. In addition, data will be presented demonstrating the utility of Adaptive’s immune profiling research tool, immunoSEQ® to quantitatively assess the immune response to novel therapies in development.

Key presentations include:

Abstract Title Date, location, Time
Late Breakers
LBA-6

 
Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study Candor Tuesday, December 10, 2019, 7:30 AM-9:00 AM

Hall D, Level 2

 
Oral Presentations
36

 
Quantitative Analysis of Minimal Residual Disease (MRD) Shows High Rates of Undetectable MRD after Fixed-Duration Chemotherapy-Free Treatment and Serves As Surrogate Marker for Progression-Free Survival: A Prospective Analysis of the Randomized CLL14 Trial Saturday, December 7, 2019: 8:45 AM
Hall D, Level 2
357

 
Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (iFCG) for First-Line Treatment of IGHV -Mutated CLL and without Del(17p)/Mutated TP53

 
Sunday, December 8, 2019: 8:00 AM
Hall E1, Level 2

 
691

 
Depth of Response to Daratumumab (DARA), Lenalidomide, Bortezomib, and Dexamethasone (RVd) Improves over Time in Patients (pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Griffin Study Update

 
Monday, December 9, 2019: 10:30 AM
Hall E1, Level 2

 
751

 
Minimal Residual Disease (MRD) Assessment in the ECOG1411 Randomized Phase 2 Trial of Front-Line Bendamustine-Rituximab (BR)-Based Induction Followed By Rituximab (R) ± Lenalidomide (L) Consolidation for Mantle Cell Lymphoma (MCL)

 
Monday, December 9, 2019: 2:45 PM-4:15 PM
Hall D, Level 2
860

 
Daratumumab, Carfilzomib, Lenalidomide and Dexamethasone (Dara-KRd) Induction, Autologous Transplantation and Post-Transplant, Response-Adapted, Measurable Residual Disease (MRD)-Based Dara-Krd Consolidation in Patients with Newly Diagnosed Multiple Myeloma (NDMM)

 
Monday, December 9, 2019: 4:45 PM
Hall E2, Level 2

 
884

 
Detectable Circulating Tumor DNA 28 Days after the CD19 CAR T-Cell Therapy, Axicabtagene Ciloleucel, Is Associated with Poor Outcomes in Patients with Diffuse Large B-Cell Lymphoma

 
Monday, December 9, 2019: 4:45 PM
W414AB, Level 4

 
927

 

 
Updated Results from an Ongoing Phase 1 Clinical Study of bb21217 Anti-Bcma CAR T Cell Therapy

 
Monday, December 9, 2019: 6:45 PM
Valencia A (W415A), Level 4 

 
602

 
Ixazomib or Lenalidomide Maintenance Following Autologous Stem Cell Transplantation and Ixazomib, Lenalidomide, and Dexamethasone (IRD) Consolidation in Patients with Newly Diagnosed Multiple Myeloma: Results from a Large Multi-Center Randomized Phase II Trial Monday, December 9, 2019: 7:15 PM
Sunburst Room (W340)

 

 
Poster Presentations
1758
Poster Presentation

 

 
Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease By Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL Patients Saturday, December 7, 2019: 5:30 PM-7:30 PM
Hall B, Level 2

 

 
1875
Poster
Presentation

 
Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant: Updated Analysis of Maia Saturday, December 7, 2019: 5:30 PM-7:30 PM
Hall B, Level 2

 
4291
Poster Presentation
High Sensitivity NGS Analysis of MRD in CLL Patients Prospectively Treated with Ibrutinib Plus FCR (iFCR)

 
Monday, December 9, 2019: 6:00 PM-8:00 PM
Hall B, Level 2 

 
4322
Poster
Presentation
Minimal Residual Disease Evaluation By Multiparameter Flow Cytometry and Next Generation Sequencing in the Forte Trial for Newly Diagnosed Multiple Myeloma Patients

 
Monday, December 9, 2019: 6:00 PM-8:00 PM
Hall B, Level 2

 
4654
Poster Presentation
Moffitt Cancer Center 2-Year Single-Institution Experience with Next-Generation Sequencing Minimal Residual Disease Detection: Clinical Utility, Application, and Correlation with Outcomes in Plasma Cell and Lymphoid Malignancies Monday, December 9, 2019: 6:00 PM-8:00 PM
Hall B, Level 2
4742
Poster Presentation
Expanded Meta-Analyses Confirms the Association between MRD and Long-Term Survival Outcomes in Multiple Myeloma (MM)

 
Monday, December 9, 2019: 6:00 PM-8:00 PM
Hall B, Level 2

About the clonoSEQ Assay

The clonoSEQ Assay was granted de novo designation and marketing authorization by FDA for the detection and monitoring of minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is the first and only FDA-authorized in vitro diagnostic assay for MRD testing. It is also the first clinical diagnostic powered by immunosequencing to receive FDA clearance. clonoSEQ leverages Adaptive’s proprietary immunosequencing 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 detect 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 are strongly associated with MRD levels measured by the clonoSEQ Assay in patients diagnosed with ALL and MM. clonoSEQ testing is covered by Medicare and an expanding list of private payors in alignment with the FDA label.

clonoSEQ is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers. 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.

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 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.

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.

MEDIA CONTACT:
Beth Keshishian
917-912-7195
media@adaptivebiotech.com

INVESTOR CONTACT:
Lynn Lewis or Carrie Mendivil
415-937-5405
investors@adaptivebiotech.com