Natera Advances Signatera™ for Bladder Cancer

Natera, Inc. (Nasdaq: NTRA) has reported positive data from its global, double-blind, randomized, Phase 3 IMvigor011 study which is evaluating outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

Natera’s data demonstrated that MIBC patients who remain Signatera MRD-negative after surgery may be spared from adjuvant treatment, with 100% overall survival at 12 months.

The company presented the analysis at the recent European Association of Urology (EAU) Congress 2024 in Paris, France. The analysis showed clinical outcomes in 171 high-risk MIBC patients who remained MRD-negative during the surveillance window, including overall survival rates of 100% at 12 months and 98% at 18 months, in patients who remained serially MRD-negative, and disease-free survival rates of 92% at 12 months and 88% at 18 months, in patients who remained serially MRD-negative.

Commenting on the study’s findings, John Simmons, vice president, BioPharma at Natera, said, “IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle-invasive bladder cancer. We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients. Together with Professor Powles and our collaborators at Genentech, we look forward to the full trial read-out which could serve as the basis of Natera’s first FDA companion diagnostic submission for Signatera.”

Natera’s study was sponsored by Genentech, a member of the Roche group.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.