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

Jun 2nd, 2022 16:10 EST

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 4th8:00 – 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 4th3:00 – 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 4th4:30 – 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 4th4:30 – 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 4th4:30 – 6:00 PM CDT
Oral Abstract 8003 Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma Sunday, June 5th9:00 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 4th8:00 – 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 6th8:00 – 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 4th8:00 – 11:00 AM CDT

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 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 AdaptiveAdaptive 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.

Forward Looking StatementsThis 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:Laura Cooper917-912-7195[email protected]

ADAPTIVE INVESTORS:Karina Calzadilla201-396-1687

Link to Source
SOTD Membership

Register by Email

or
Already a member? Sign In