Janssen Biotech to Use Adaptive’s clonoSEQ Assay in Darzalex Myeloma Trials

Adaptive Biotechnologies said today it will partner with Johnson & Johnson’s Janssen Biotech to develop its next-generation sequencing (NGS)-based clonoSEQ Assay as a companion diagnostic in ongoing and future clinical trials assessing Darzalex (daratumumab) in patients with multiple myeloma (MM).

The value of the collaboration was not disclosed.

The companies will use clonoSEQ Assay for measuring minimal residual disease (MRD) in MM patients who have been treated with Darzalex, a marketed CD38-directed cytolytic antibody approved for three indications in relapsed or refractory multiple myeloma.

clonoSEQ Assay is designed to detect individual DNA sequences associated with cancer. According to Adaptive, the diagnostic has been developed to detect and quantify MRD in lymphoid malignancies, help monitor patients’ treatment response and remission status, and aid early detection of disease relapse, potentially before symptoms recur.

Adaptive said it will receive from Janssen an undisclosed upfront technology access payment, plus development funding and potential future milestone payments.

The partners aim to demonstrate the clinical utility of the clonoSEQ assay for monitoring MRD negativity in MM patients, and will also assess the drug’s ability to achieve MRD. Adaptive has agreed to pursue regulatory approval of the clonoSEQ Assay in MM, as well as commercialize the diagnostic.

“We look forward to advancing our strategic partnership with Janssen by incorporating the highly sensitive and quantitative clonoSEQ Assay into more trials with Darzalex,” Chad Robins, Adaptive’s CEO and cofounder, said in a statement.

Darzalex was first granted FDA accelerated approval in November 2015 as a monotherapy for MM patients who had received at least three prior lines of therapy. The FDA approved the drug in November 2016 as a combination therapy with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for the treatment of MM patients who have received at least one prior therapy. The European Commission granted full approval for the drug for the same indication, in April 2017.

On Friday, the FDA extended approval of Darzalex as combination therapy with pomalidomide and dexamethasone for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

Adaptive’s collaboration with Janssen is the second clonoSEQ Assay partnership announced this year by the company with a biopharma giant. In January, Adaptive launched a partnership with Amgen to assess MRD in patients with Acute Lymphoblastic Leukemia (ALL). The collaboration, whose value was also not disclosed, is designed to build data for MRD as a validated measure of patient outcomes in ALL.