As Relevance of MRD Testing Grows, So Does Access

As minimal residual disease (MRD) and other measures to detect cancer burden are increasingly used to predict outcomes and direct future treatment decisions, Amgen has chosen to partner with Adaptive Biotechnologies to use the clonoSEQ product to assess MRD across multiple drug development programs.

For instance, in new study results for the use of blinatumomab in pediatric high-risk, B-cell acute lymphoblastic leukemia, Amgen announced that enrollment in the phase 3 trial was terminated early because of encouraging efficacy that included MRD data. That decision was based on improved disease-free survival and overall survival, lower toxicity, and better MRD compared with chemotherapy.

"It is critical to know a patient’s MRD status because treating to MRD negativity has been shown to drive better clinical outcomes for patients in a variety of blood cancers," Gregory Friberg, MD, vice president of global development at Amgen, said in a statement.

As part of the partnership, Adaptive will provide MRD testing and analysis for ongoing and future trials. Amgen and Adaptive have been working together since 2016, but the new partnership is a global agreement within Amgen’s hematology portfolio. Adaptive will be able to leverage the data it generates as part of its work with Amgen to build robust evidence supporting MRD as a validated measure of patient outcomes across treatments and blood cancers.

The same day as the announcement of the partnership with Amgen, Adaptive also announced that it would be making clonoSEQ available so hospitals and health systems can run the assays in their local laboratories across the country, increasing access to MRD assessment and monitoring.

Currently, the clonoSEQ test to monitor MRD is performed at Adaptive’s lab in Seattle after a clinician orders the test. The test will be available through a partnership with Illumina, which will develop in-vitro diagnostic kits to expand the availability of clonoSEQ.

“By making Adaptive’s clonoSEQ more accessible to patients, we are ensuring healthcare providers have access to a valuable part of a growing genomics ecosystem,” Phil Febbo, MD, chief medical officer of Illumina, said in a statement. “Partnerships that bring exceptional clinical content to customers and patients represent an exciting opportunity in clinical genomics.”