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Adaptive Biotechnologies, Genentech Partner on MRD Testing in Venetoclax Clinical Trial

NEW YORK – Adaptive Biotechnologies announced Monday an agreement with Genentech to use Adaptive's ClonoSeq assay to assess minimal residual disease (MRD) in patients participating in a Phase III clinical trial.

Under the terms of the global, multi-year agreement, Genentech, a Roche subsidiary, will use the ClonoSeq assay to assess MRD in response to venetoclax treatment for patients newly diagnosed with chronic lymphocytic leukemia (CLL.) The agreement also covers use of ClonoSeq in future venetoclax studies in CLL. The firms will incorporate ClonoSeq to measure MRD status as a primary endpoint.

Genentech's venetoclax is a small molecule selective B-cell lymphoma-2 (BCL-2) inhibitor in clinical trials for the treatment of people with previously untreated CLL or small lymphocytic lymphoma.

Adaptive will receive upfront and sample testing payments. Other details were not disclosed.

"Adaptive is pleased to partner with Genentech to support the continued clinical development and potential regulatory approval of venetoclax in people with untreated CLL, which expands our work with Genentech in oncology," Adaptive CEO and Cofounder Chad Robins said in a statement. "This partnership represents another significant step towards the adoption of MRD status as a primary clinical endpoint using ClonoSeq as the preferred MRD test. This is Adaptive's second meaningful partnership which we recently announced that includes the use of ClonoSeq in the development of venetoclax."

ClonoSeq is a next-generation sequencing-based in vitro diagnostic test approved by the US Food and Drug Administration to detect and monitor MRD in multiple myeloma and B-Cell acute lymphoblastic leukemia. For CLL, it is only available as a laboratory-developed test, using peripheral blood and bone marrow samples.

Adaptive and Genentech added that they will evaluate the depth and duration of response to venetoclax and obinutuzumab by using ClonoSeq as a primary endpoint to measure and monitor MRD negativity from peripheral blood in newly diagnosed CLL.

In August 2019, Adaptive announced it would pursue expanded FDA clearance for ClonoSeq, including for blood-based MRD testing for patients with CLL and non-Hodgkin's lymphoma.