Bristol-Myers Squibb (BMS) and Natera, Inc. Have entered into an agreement to investigate Natera’s Signatera circulating tumor DNA (ctDNA) assay as a potential biomarker for BMS’s immunotherapy drug, Opdivo (nivolumab), in a Phase 2 clinical trial for non-small cell lung cancer (NSCLC), the companies announced in September 2018.
The study will focus on patients with NSCLC who have undergone surgical resection. Signatera will be used to identify patients with minimal residual disease (MRD) following surgery, who will then receive either standard adjuvant care or standard care combined with Opdivo. The collaboration aims to determine if ctDNA levels detected by Signatera can predict which patients are most likely to benefit from Opdivo, according to a press release from Natera.
The first patient enrollment was anticipated in 2019, contingent upon Natera completing validation of the Signatera ctDNA assay under the Clinical Laboratory Improvement Amendments (CLIA). The trial is being led by Charles Swanton, M.D., Ph.D., of the Francis Crick Institute in London. Natera’s prior research with Dr. Swanton and the UCL Cancer Institute, published in Nature in 2017, contributed to the development and early clinical validation of the Signatera approach in NSCLC.
Natera, a global leader in cell-free DNA testing, developed Signatera as a custom ctDNA assay. The agreement with BMS highlights the growing interest in using ctDNA as a biomarker to personalize cancer treatment. Lung cancer remains a leading cause of cancer-related deaths in the United States, according to Natera.
Several individuals involved in the research and development of Signatera and the related trials have disclosed potential conflicts of interest. Specifically, C.H., S.K.C., S.S., and A.C.E. Are full-time employees of Natera, Inc. And hold stocks or options to acquire stocks in the company. M.S.v.d.H. Has received institutional funding from Bristol Myers Squibb and has various consulting and research support arrangements with multiple pharmaceutical companies, including Astellas, AstraZeneca, and Roche. Other authors have disclosed consulting fees, advisory roles, and research support from a range of pharmaceutical companies, including Johnson & Johnson, Merck, Pfizer, and Janssen.