Adaptive Biotech And Collaborators Demonstrate Importance Of Minimal Residual Disease Measurement In Response Evaluation For Multiple Myeloma

SEATTLE--(BUSINESS WIRE)--Adaptive Biotechnologies today announced the recent publication of a study in JAMA Oncology that demonstrates that measurement of minimal residual disease (MRD) is a critical tool in evaluating response to new highly effective drug combinations for the treatment of multiple myeloma.

“Given the depth of response seen in multiple myeloma patients treated with three-drug combinations, there is an increased need for clinical trials to go beyond traditional methods of response evaluation and incorporate MRD detection and quantification”

“Given the depth of response seen in multiple myeloma patients treated with three-drug combinations, there is an increased need for clinical trials to go beyond traditional methods of response evaluation and incorporate MRD detection and quantification,” said Tom Willis, PhD, Senior Vice President and General Manager, Diagnostic Products, Adaptive Biotechnologies. “For individual patients receiving these treatments there is also a role for MRD testing, as several studies have shown that MRD-negativity predicts progression-free survival and overall survival.”

The new study, conducted in collaboration with researchers from academic institutions including the National Cancer Institute and Memorial Sloan Kettering Cancer Center, investigated the three-drug combination known as CRd (carfilzomib, lenalidomide and dexamethasone) followed by two years of lenalidomide maintenance therapy in patients with newly diagnosed multiple myeloma (NDMM; n=45) or high-risk smoldering multiple myeloma (SMM; n=12).

Twenty-eight of the NDMM patients (62 percent) and all 12 of the SMM patients achieved a near complete response (nCR) or better as measured by standard criteria. Among these patients, 28/28 and 11/12 were MRD-negative when assessed with flow cytometry, respectively. When the more sensitive next-generation sequencing-based MRD detection and quantification method (available clinically from Adaptive Biotechnologies as the clonoSEQ^® Process) was used, 14/21 evaluable NDMM and 9/12 SMM patients were found to be MRD-negative.

The study, “Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma” by Korde et al., was published online ahead of print in JAMA Oncology on July 2, 2015. An accompanying invited editorial, “Multiple Myeloma—Better Drugs Ask for More Stringent Evaluations” by Pieter Sonneveld, MD, PhD, was simultaneously published.

About Minimal Residual Disease

Minimal residual disease (MRD) refers to cancer cells that may remain in the body of a person with lymphoid cancer after treatment. These cells are present at levels undetectable by traditional microscopic examination (also called morphologic examination) of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as the next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ MRD Test, are needed for reliable detection of very low levels of MRD.

About the clonoSEQ^® Process

The Adaptive Biotechnologies clonoSEQ Process enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as an aid to clinical decision making for patients with lymphoid cancers (blood cancers). With its ability to detect cancer cells at a level as low as one per one million white blood cells, the clonoSEQ MRD Test is one to two orders of magnitude more sensitive than other methods of MRD detection, such as ASO-PCR and flow cytometry. The clonoSEQ Process was previously marketed as the ClonoSIGHT™ process by Sequenta, Inc., which was acquired by Adaptive Biotechnologies in January 2015.

MRD detection and quantification using the clonoSEQ Process involves two steps that are easily integrated into patient care. In the first step, the clonoSEQ ID Test, cancer cell DNA sequences are identified in a diagnostic sample. In the second step, the clonoSEQ MRD Test, follow-up samples are screened for the previously identified sequences in order to detect residual disease. ClonoSEQ test results are generated in seven days using the company’s CLIA-certified, CAP-accredited laboratory. These results are provided to the ordering physician in a simple, actionable report that shows a patient’s MRD status and level, as well as MRD trends over time via a secure online portal.

About Adaptive Biotechnologies

Adaptive Biotechnologies is the 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 also translates immunosequencing discoveries into clinical diagnostics and therapeutic development to improve patient care.