Adaptive Biotechnologies and its collaborators have presented data at the American Society of Hematology (ASH) Annual Meeting showing that the clonoSEQ® minimal residual disease (MRD) Test can predict which multiple myeloma (MM) patients undergoing autologous ("self") transplant will benefit from post-transplant treatment with novel therapies.

"Autologous stem cell transplantation in conjunction with therapeutic drugs can dramatically improve response rates and the prognosis of patients with multiple myeloma. However, most patients with myeloma are considered to be incurable and relapse owing to MRD is the main cause of death among these patients," said the study's lead author, Hiroyuki Takamatsu, M.D., Ph.D., Assistant Professor, Department of Cellular Transplantation Biology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan. "Assessing MRD in the autograft product and after transplant can predict outcomes and help guide treatment decisions."

Patients with newly diagnosed MM who had received various induction regimens followed by autologous stem cell transplantation were followed between June 15, 2004 and April 25, 2015. Autograft samples from 98 patients were analyzed using the clonoSEQ MRD Test, with MRD-negativity defined as less than one myeloma cell per million white blood cells (10-6). In patients with MRD-negative autografts (n=19), receiving post-transplant treatment with a novel therapy did not affect progression-free survival (PFS) or overall survival (OS) (both 100 percent at 5 years). However, in patients whose autografts were MRD-positive (n=79), receiving post-transplant treatment with a novel therapy (n=45) had a significant positive impact on PFS, as well as a trend toward improved OS (5 year PFS: 49.2% vs. 25.2%, p=0.003).

"These results suggest that therapeutic intervention based on NGS-based MRD-positivity could have a significant effect on myeloma patient outcome in the post-autologous transplant setting," said Tom Willis, Ph.D., Senior Vice President and General Manager, Diagnostic Products, Adaptive Biotechnologies. "This data is further evidence of the utility of MRD assessment throughout myeloma treatment."

Other analyses from the same cohort of patients were consistent with previous studies showing the prognostic power of MRD in MM. PFS was improved in 1) patients with MRD-negative autografts compared to those with MRD-positive autografts, regardless of post-transplant treatment and 2) in patients whose bone marrow was MRD-negative post-transplant, in total and when analysis was restricted to only those patients in complete response (CR).

Abstract No. 1788: Prognostic Value of Sequencing-Based Minimal Residual Disease Detection in Patients with Multiple Myeloma Who Underwent Autologous Stem Cell Transplantation

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.