Studies demonstrate value of MRD in novel treatment settings including CAR T cell therapy and in a growing range of patient types, including Non-Hodgkin’s Lymphoma
SEATTLE, June 03, 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, will be included in more than 20 abstracts studying the use of Adaptive’s clonoSEQ® Assay for minimal residual disease (MRD) assessment at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, and the European Hematology Association (EHA) Virtual Congress from June 9-17. 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 (MM) and B-cell acute lymphoblastic leukemia (B-ALL), and is widely available to clinicians and patients across the U.S.
“What is particularly notable at ASCO and EHA this year is the breadth of clinical use cases for MRD that are represented,” said Lance Baldo, MD, Chief Medical Officer of Adaptive Biotechnologies. “Both clinician investigators and pharmaceutical companies have found new settings in which deep responses by clonoSEQ are achievable, which is excellent news for patients and also evidence of the growing role that clonoSEQ MRD monitoring can play across the lymphoid cancer care continuum.”
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 information about how a patient may be responding to treatment, so patients and providers can be in control when it comes to managing the disease and treatment decisions.
Data at ASCO and EHA illustrates the relevance of MRD assessment post-CAR T cell therapy, in MM patients who are often heavily pretreated and who in the past might not have been expected to have such deep responses. Similarly, data showing the ability to achieve deep responses in high-risk patients supports the growing range of patient settings in which MRD assessment is valuable. Both meetings also include data showcasing the importance of serial monitoring of MRD using clonoSEQ as a primary endpoint. These data demonstrate that understanding the kinetics of low-level disease over time – which can only be ascertained using a highly sensitive and precisely quantitative MRD assay like clonoSEQ – is vital to clinicians’ ability to accurately understand prognosis and even more clinically meaningful than a single point-in-time measurement.
Key presentations include:
|EHA S146 (oral)||Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 4-year follow up analysis of the randomized CLL14 study||on demand|
|ASCO – 8005 (oral)||Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1.||Tuesday, June 8 8:00 AM – 11:00 AM EDT|
|ASCO – 8016 (poster)||Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T cell therapy, in relapsed and refractory multiple myeloma: Updated KarMMa results||Friday, June 4 9:00 AM EDT|
|ASCO – TPS 8054||Subcutaneous daratumumab (DARA SC) plus lenalidomide versus lenalidomide alone as maintenance therapy in patients (pts) with newly diagnosed multiple myeloma (NDMM) who are minimal residual disease (MRD) positive after frontline autologous stem cell transplant (ASCT): The phase 3 AURIGA study.||Friday, June 4 9:00 AM EDT|
|ASCO – 8011 (poster)/EHA EP1010||Interim analysis of a phase 2 minimal residual disease (MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma (MM).||Friday, June 4 9:00 AM EDT/on demand|
|ASCO – 8004 (oral)||Daratumumab (DARA) maintenance or observation (OBS) after treatment with bortezomib, thalidomide and dexamethasone (VTd) with or without DARA and autologous stem cell transplant (ASCT) in patients (pts) with newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 2||Tuesday, June 8 8:00 AM – 11:00 AM EDT|
|7505 (oral)||The combination of venetoclax, lenalidomide, and rituximab in patients with newly diagnosed mantle cell lymphoma induces high response rates and MRD undetectability.||Monday, June 7 11:30 AM - 2:30 PM EDT|
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.
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 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.
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Carrie Mendivil, Gilmartin Group