Companies Collaborating to Use ClonoSEQ Assay in Multiple Myeloma Trials Testing Isatuximab

Companies Collaborating to Use ClonoSEQ Assay in Multiple Myeloma Trials Testing Isatuximab
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clonoSEQ Assay sanofi

Adaptive Biotechnologies is collaborating with Sanofi to use its clonoSEQ Assay for measuring minimal residual disease in multiple myeloma patients receiving isatuximab, a treatment candidate for newly diagnosed, relapsed or refractory multiple myeloma.

Through this partnership, researchers will test clonoSEQ’s ability to both measure minimal residual disease (MRD) and determine the clinical value of monitoring MRD in isatuximab-treated patients.

“MRD status is being incorporated as an important clinical endpoint to assess response to therapy in patients with multiple myeloma and other lymphoid malignancies,” Charles Sang, senior vice president of diagnostics at Adaptive Biotechnologies, said in a press release. “We are excited to work with Sanofi on its late-stage MM [multiple myeloma] trials to help demonstrate the clinical utility of achieving MRD negativity in isatuximab-treated patients.”

In blood cancers, MRD refers to a small number of malignant cells that remain in the body after treatment is complete. These cells can sometimes be present at levels undetectable by traditional diagnostic methods, and so they can persist and proliferate, causing a relapse of the disease.

Adaptive’s clonoSEQ Assay is an innovative diagnostic tool using next-generation DNA sequencing to simultaneously evaluate the unique genetic patterns of B-cell and T-cell receptors in a single sample. The assay can overcome some of the limitations of current methods to monitor MRD because it promotes the analysis of a broad variety of genetic information with high sensitivity to detect remaining malignant cells against a background of millions of normal cells.

As a result ClonoSEQ Assay can accurately measure disease burden, which helps doctors predict long-term outcomes, assess treatment responses, monitor remission status, and detect relapses sooner.

Under the terms of the agreement, Adaptive will be responsible for seeking the regulatory approval and marketing of clonoSEQ Assay for multiple myeloma in select countries.

“Adaptive is thrilled to apply its technology to help determine the depth and duration of response to isatuximab in multiple myeloma-treated patients,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “We look forward to kicking off our collaboration and applying our validated, highly sensitive and quantitative clonoSEQ Assay to measure MRD status as a clinical endpoint in Sanofi’s clinical trials.”

This follows a previous collaboration with Amgen for the use of clonoSEQ Assay to assess MRD in patients with acute lymphoblastic leukemia and relapsed or refractory multiple myeloma, and is the fourth collaboration agreement with other pharmaceutical companies.

Isatuximab is an investigational anti-CD38 antibody in late-stage clinical development. A Phase 3 trial, called IMROZ (NCT03319667), is assessing the medicine in newly diagnosed myeloma patients. Two other Phase 3 trials — IKEMA (NCT03275285) and ICARIA-MM (NCT02990338) — are studying combinations of isatuximab in relapsed or refractory patients.

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