Natera Signs Agreement with Bristol-Myers Squibb to Investigate Signatera ctDNA Assay

Natera, Inc., a global leader in cell-free DNA testing, announced an agreement with Bristol-Myers Squibb to use Natera’s Signatera custom circulating tumor DNA (ctDNA) assay in a Phase 2 study in the adjuvant non-small cell lung cancer (NSCLC) setting. The study will use the Signatera ctDNA assay to select patients who have minimal residual disease (MRD) after surgical resection to receive adjuvant standard of care with or without Opdivo (nivolumab). The first patient is anticipated to enroll in 2019 once Natera completes validation of its Signatera ctDNA assay under the Clinical Laboratory Improvement Amendments (CLIA). This study represents the first prospective clinical trial using Natera’s Signatera ctDNA assay in adjuvant NSCLC. The study is being led by Charles Swanton, M.D., Ph.D., Senior Group Leader, Translational Cancer Therapeutics Laboratory, Francis Crick Institute, London. Natera’s previous research collaboration with Dr Swanton and the UCL Cancer Institute team in the TRACERx study, which culminated in a publication in Nature in 2017, was important for the development and early clinical validation of Natera’s approach in NSCLC.

Lung cancer is the second most common cancer (excluding skin cancer), and is the leading cause of cancer death in the US Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. The five-year survival rate is 56 percent when localized and detected early; however, 16 percent of cases are detected at this stage. The five-year survival rate for non-localized tumors, which have spread to other organs, is only 5 percent. “We are excited to use our ctDNA assay to potentially help define a new way to detect and treat early-stage lung cancer patients,” said Alexey Aleshin, M.D., M.B.A., Oncology Medical Director, Natera. “We are also pleased to have been chosen as the first ctDNA assay to be used in a prospective outcomes study to inform adjuvant NSCLC treatment.”

“Our goal is to potentially use the learnings from this study to serve as Natera’s framework with other companies to investigate novel approaches from the metastatic setting in early-stage treatment,” said Matthew Rabinowitz, Ph.D., Natera CEO. “We believe that our technology will potentially enable treatment selection for patients most likely to benefit.” Natera estimates that there are approximately 12.6 million people in the U.S. who have been diagnosed with early-stage cancer across tumor types. In addition to this trial, 24 studies have been signed so far with 19 companies, covering most of the top ten pharmaceutical companies. These studies include prospective trials correlating clinical response with ctDNA levels for personal cancer vaccines, as well as targeted therapies. Combined with previously disclosed investigator-initiated studies in breast, lung, colorectal, and bladder cancer, these studies lay the foundation for Signatera’s clinical validation as a pan-cancer assay. – Medical Buyer Bureau