Adaptive Biotechnologies, a leader in combining next-generation sequencing (NGS) and sophisticated bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announces it has entered into a collaboration agreement with Amgen to utilize Adaptive’s NGS-based clonoSEQ Assay in the Phase 3 CANDOR study, sponsored by Amgen in collaboration with Janssen, comparing Kyprolis® (carfilzomib), Darzalex® (daratumumab), and dexamethasone with Kyrpolis and dexamethasone. Adaptive’s NGS-based clonoSEQ Assay will be utilized to measure minimal residual disease (MRD) status in patients with relapsed or refractory Multiple Myeloma (MM).
“Incorporating MRD measurement by the clonoSEQ Assay offers Amgen the ability to accurately assess the depth of response generated by Kyprolis treatment in patients with relapsed or refractory MM,” said Chad Robins, President, CEO and Co-Founder of Adaptive Biotechnologies. “This is the second collaboration with Amgen to assess MRD in oncology clinical studies, and we are thrilled to continue to expand our work with such an industry-leading partner.”
Announced in January, the first collaboration with Amgen assesses MRD in patients with Acute Lymphoblastic Leukemia (ALL). Through this second collaboration, the companies will work towards further demonstrating the clinical utility of MRD detection in patients with repalsed or refractory MM treated with Kyprolis.
About Minimal/Measurable Residual Disease
Minimal/measurable residual disease (MRD) in hematologic malignancies refers to cancer cells that remain in the body of a person with cancer after treatment. These cells can be present at levels undetectable by traditional morphologic, microscopic examination of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ Assay, are needed for reliable detection of MRD at levels below the limits of traditional assessment.
About the clonoSEQ® Assay
The Adaptive Biotechnologies clonoSEQ Assay enables physicians to utilize a molecular, next-generation sequencing-based minimal/measureable residual disease (MRD) detection method. The clonoSEQ Assay detects and quantifies DNA sequences found in malignant cells which can be tracked throughout treatment. This robust assay provides consistent, accurate measurement of disease burden which potentially allows physicians to visualize response to treatment over time. Adaptive intends to seek 510(K) marketing authorization from FDA for the clonoSEQ Assay.
About Adaptive Biotechnologies®
Adaptive Biotechnologies is a pioneer and leader in combining high-throughput sequencing and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immunosequencing platform into laboratories around the world to drive groundbreaking research in cancer and other immune-mediated diseases. Adaptive’s mission is to translate immunosequencing discoveries into clinical diagnostics and therapeutics to improve patient care. For more information, please visit adaptivebiotech.com