Adaptive Biotechnologies has partnered with Amgen to use Adaptive’s NGS-based clonoSEQ Assay in a Phase 3 clinical trial led by Amgen to measure minimal residual disease (MRD) status in patients with relapsed or refractory multiple myeloma (MM).
The Phase 3 CANDOR study (NCT03158688), co-sponsored by Amgen and Janssen, is assessing if adding Darzalex (daratumumab) to Kyprolis (carfilzomib) and dexamethasone lengthens the time to disease progression in multiple myeloma patients who received one to three prior therapies.
MRD in blood disorders refers to cancer cells that remain in the body after treatment. These cells can sometimes be present at levels that are undetectable by traditional morphologic, microscopic examination of blood or bone marrow, or of a lymph node biopsy. However, sensitive molecular technologies, such as the clonoSEQ Assay, can detect MRD at levels below the limits of so-called traditional assessment.
Adaptive’s clonoSEQ Assay uses a sequencing-based method that provides consistent, accurate measurements of disease burden to help physicians predict long-term outcomes, assess treatment responses, monitor remission status, and detect relapses sooner.
“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,” Chad Robins, president, chief executive officer, and co-founder of Adaptive Biotechnologies, said in a press release. “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.”
Adaptive and Amgen announced their first collaboration in January 2017 to assess MRD in patients with acute lymphoblastic leukemia (ALL). Through this second collaboration, the partners aim to further demonstrate the clinical utility of MRD detection in patients with relapsed or refractory myeloma who have received treatment with Kyprolis.
Adaptive’s clonoSEQ is innovative in its use of next-generation DNA sequencing (NGS), an advance in DNA sequencing technology that enables simultaneous identification of unique B-cell and T-cell receptors from a single sample.
NGS can be a useful approach for monitoring MRD because it makes it possible for physicians to characterize a broad variety of genetic information and enables the differentiation of very small numbers of remaining malignant cells against a background of millions of normal cells.
Adaptive announced that it will seek 510(K) marketing authorization from the U.S. Food and Drug Administration (FDA) for the clonoSEQ Assay.