Business
Adaptive and Genentech Partner to Use clonoSEQ® Assay to Measure Minimal Residual Disease as a Primary Endpoint in Phase III Study of Chronic Lymphocytic Leukemia Patients
SEATTLE, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate
About this update from Adaptive Biotechnologies Corporation
[{"type":"text","content":"SEATTLE, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced a multi-year, global diagnostic agreement with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) to utilize Adaptive’s next-generation sequencing (NGS)-based clonoSEQ® Assay to assess minimal residual disease (MRD) status in response to venetoclax in the registrational Phase III CRISTALLO (CO41685) study for the treatment of newly diagnosed people with chronic lymphocytic leukemia (CLL) plus additional future venetoclax studies in CLL. Adaptive and Genentech will partner to incorporate the clonoSEQ Assay to measure MRD status as a primary endpoint in this registrational study. Under the terms of the agreement, Adaptive will receive upfront and sample testing payments to advance the development and potential expedited approval of venetoclax in this setting.\n “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,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “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.” Venetoclax is a first-in class small molecule selective B-cell lymphoma-2 (BCL-2) inhibitor being studied in investigational trials for the treatment of people with previously untreated CLL or small lymphocytic lymphoma (SLL). Adaptive and Genentech will evaluate the depth and duration of response to venetoclax and obinutuzumab by using Adaptive’s clonoSEQ Assay as a primary endpoint to measure and monitor MRD negativity from peripheral blood in newly diagnosed CLL. clonoSEQ is the only MRD test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor MRD in multiple myeloma (MM) and B-Cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. clonoSEQ is available ...