On May 29, 2019 Adaptive Biotechnologies and its collaborators will present data from more than 15 studies for clonoSEQ and immunoSEQ at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 31 – June 4 (Press release, Adaptive Biotechnologies, MAY 29, 2019, View Source [SID1234536667]).
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"At Adaptive, we are decoding the adaptive immune system to help diagnose and treat disease. With our FDA-cleared NGS MRD Assay, clonoSEQ, we are enabling physicians in clinical practice to monitor and track a patient’s minimal residual disease (MRD) status to predict outcomes and guide treatment decisions. Additionally, our immunoSEQ research tool is helping to validate response to immunotherapies and assess toxicity," said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. "We remain committed to expanding the clinical applications of our immune medicine platform to reach greater numbers of patients."
clonoSEQ at ASCO (Free ASCO Whitepaper)
New clonoSEQ data will continue to demonstrate the impact of our Assay on assessing and monitoring MRD from a patient’s bone marrow sample for approved indications, such as multiple myeloma, as well as other blood cancers uses, such as Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-cell Lymphoma (DLBCL). Additionally, we will see increased use of clonoSEQ in studies to help assess treatment response for novel therapies like CARTs and anti-CD38. These new data support the need for a standardized, sensitive, reliable MRD test in multiple disease settings, across numerous therapies, as well as the importance of MRD monitoring in a real-world clinical setting.
clonoSEQ presentations of interest include:
Abstract Title Date, location, Time
8003
Oral Presentation
Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results Sunday, June 2, 10:45 a.m. CT, Location: E451
8004
Oral Presentation
A phase III randomized, open label, multicenter study comparing isatuximab, pomalidomide, and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) Sunday, June 2 at 10:57 a.m. CT, Location: E451
7552
Poster Presentation
Poster 306
Monitoring ctDNA in r/r DLBCL patients following the CAR T-cell therapy axicabtagene ciloleucel: Day 28 landmark analysis Monday, June 3, 8:00 – 11:00 a.m., CT Location: Hall A
8026
Poster Presentation
Poster 352
Minimal residual disease (MRD) clinical monitoring and depth of response in multiple myeloma Monday, June 3, 8:00 – 11:00 a.m. CT, Location: Hall A
7501
Oral Presentation
TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Tuesday, June 4 at 9:57 a.m. CT, Location: E451
7502
Oral Presentation
Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities Tuesday, June 4, 10:09 a.m. CT, Location: E451
immunoSEQ at ASCO (Free ASCO Whitepaper)
immunoSEQ is being used in the research setting to predict response to immunotherapies and to monitor toxicity in solid tumors including pancreatic cancer. Data for immunoSEQ will demonstrate how the product is being used in large-scale clinical trials. Specifically, data will highlight how immunoSEQ can help to identify predictive biomarkers, as well as assess longitudinally patient response to therapies, including checkpoint inhibitors, Fc enhanced monoclonal antibodies, and cancer vaccines.
immunoSEQ presentations of interest include:
Abstract Title Date, location, Time
2541
Poster 367
Clonal expansion of tumor infiltrating leukocytes (tils) in the peripheral blood of metastatic melanoma patients is significantly associated with response to CTLA4 blockade-based immunotherapy Saturday, June 1, 8:00 – 11:00 a.m. CT, Location: Hall A
1030
Poster 111
High frequency of HER2-specific immunity observed in patients (pts) with HER2+ cancers treated with margetuximab (M), an Fc-enhanced anti-HER2 monoclonal antibody (mAb) Sunday, June 2, 8:00-11:00 a.m. CT, Location: Hall A
About the clonoSEQ Assay
The clonoSEQ Assay is the first and only FDA-cleared in vitro diagnostic assay 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 also the first clinical diagnostic assay powered by immunosequencing to receive FDA clearance. It 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 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.