Natera and Bristol Myers Squibb Collaborate to Advance Lung Cancer Treatment with ctDNA Assay

Natera, Inc. And Bristol Myers Squibb have joined forces to investigate the potential of Natera’s Signatera™ circulating tumor DNA (ctDNA) assay as a biomarker for Opdivo (nivolumab) in a Phase 2 clinical trial for adjuvant non-small cell lung cancer (NSCLC). This collaboration aims to identify patients who may benefit most from immunotherapy following surgical resection.

Signatera ctDNA Assay and Minimal Residual Disease

The study will utilize the Signatera ctDNA assay to select patients exhibiting minimal residual disease (MRD) after surgery. These patients will then receive either standard adjuvant care or standard care combined with Opdivo (nivolumab). The goal is to determine if ctDNA levels can predict response to immunotherapy and improve patient outcomes.

About the Collaboration

The agreement, initially announced in September 2018, represents the first prospective clinical trial employing Natera’s Signatera ctDNA assay in the adjuvant NSCLC setting. Enrollment is anticipated to initiate after Natera completes validation of the Signatera ctDNA assay under the Clinical Laboratory Improvement Amendments (CLIA).

Previous Research and Development

This collaboration builds upon prior research led by Dr. Charles Swanton and the UCL Cancer Institute team in the TRACERx study. Findings from the TRACERx study, published in Nature in 2017, were instrumental in the development and early clinical validation of Natera’s ctDNA approach for NSCLC. Source

Signatera and Bristol Myers Squibb: A Continued Partnership

Bristol Myers Squibb is investigating Signatera as a biomarker to identify NSCLC patients who might respond favorably to Opdivo immunotherapy. Source The company, a global biopharmaceutical leader, is committed to discovering and delivering innovative medicines for serious diseases. Source

What is ctDNA?

Circulating tumor DNA (ctDNA) is DNA released from cancer cells into the bloodstream. Analyzing ctDNA can provide valuable insights into the presence, stage and treatment response of cancer. Signatera is a custom ctDNA assay designed to detect and quantify ctDNA with high sensitivity and specificity.

Lung Cancer Statistics

Lung cancer remains a significant health challenge, being the second most common cancer (excluding skin cancer) and the leading cause of cancer-related deaths in the United States.