Adaptive Biotechnologies Included in Key Abstracts at ASCO 2022 Supporting the Role of the clonoSEQ® Assay as a Standard for MRD Assessment Technology

SEATTLE, June 02, 2022 (GLOBE NEWSWIRE) -- Data from 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, will be included in several abstracts investigating the impact of MRD in blood cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 3-7, in Chicago, Illinois. clonoSEQ^® is the first and only U.S. Food and Drug Administration (FDA)-cleared assay for measuring minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S.

MRD is a term used to quantify the number of cancer cells that may remain in a patient’s body after treatment, even in the absence of symptoms. These residual cells can be present at very low levels and require highly sensitive tests like clonoSEQ to identify them. The presence of even a small number of cells offers prognostic value to clinicians as they assess how patients respond to treatment. MRD status may ultimately predict clinical relapse.

“We are excited by the data from both investigator-sponsored and pharmaceutical-driven presentations utilizing clonoSEQ at ASCO this year, particularly for novel and highly targeted therapies,” said Nitin Sood, Chief Commercial Officer, MRD, Adaptive Biotechnologies. “The burgeoning evidence base supports the expansion of clonoSEQ as a standard in MRD assessment for lymphoid cancers and emphasizes the importance of MRD assessment using clonoSEQ in day-to-day care for patients and physicians.”

Data using clonoSEQ for MRD assessment will be presented across a range of cancers including multiple myeloma, ALL, CLL and non-Hodgkin’s lymphoma (NHL) and underscore the significance of deep responses and identification of patients with better outcomes.

Key presentations include:

Presentation Type and Number	Title	Presentation Timing
Multiple Myeloma
Poster Abstract 8028	Phase 1b/2 study of ciltacabtagene autoleucel, a BCMA-directed CAR-T cell therapy, in patients with relapsed/refractory multiple myeloma (CARTITUDE-1): Two years post-LPI	Saturday, June 4th 8:00 – 11:00 AM CDT
Poster Abstract 7518	Three-year follow-up of outcomes with KTE-X19 in patients with relapsed/refractory mantle cell lymphoma in ZUMA-2	Saturday, June 4th 3:00 – 4:30 PM CDT
Poster Abstract 8014	Elranatamab, a BCMA-targeted T-cell redirecting immunotherapy, for patients with relapsed or refractory multiple myeloma: Updated results from MagnetisMM-1	Saturday, June 4th 4:30 – 6:00 PM CDT
Poster Abstract 8011	Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): A post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN	Saturday, June 4th 4:30 – 6:00 PM CDT
Poster Abstract 8020	Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in lenalidomide (len)-refractory patients (pts) with progressive multiple myeloma (MM) after 1–3 prior lines of therapy (LOT): CARTITUDE-2, cohort A	Saturday, June 4th 4:30 – 6:00 PM CDT
Oral Abstract 8003	Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma	Sunday, June 5th 9:00 AM CDT
Smoldering Multiple Myeloma
Poster Abstract 8040	B-PRISM (Precision Intervention Smoldering Myeloma): A phase II trial of combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in high-risk smoldering multiple myeloma	Saturday, June 4th 8:00 – 11:00 AM CDT
Acute Lymphoblastic Leukemia
Poster Abstract 10023	Minimal residual disease comparison between Ig/TCR PCR versus NGS assays in children with Philadelphia chromosome-positive acute lymphoblastic leukemia: A report from the COG AALL1631 study	Monday, June 6th 8:00 – 11:00 AM CDT
non-Hodgkin Lymphoma
Poster Abstract 7531	Molecular disease monitoring in patients with relapsed/refractory B-cell non-Hodgkin lymphoma receiving anti-CD19 CAR T-cell therapy	Saturday, June 4th 8:00 – 11:00 AM CDT

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 Adaptive
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 our Immune Medicine and Minimal Residual Disease (MRD) businesses. 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. For more information, please visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.

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