Natera’s Positive Analysis in IMvigor011 Trial for Bladder Cancer

Natera, a leader in cell-free DNA testing, presents findings from the IMvigor011 study at the EAU Congress 2024. The analysis focuses on muscle-invasive bladder cancer (MIBC) patients who tested negative with Signatera™, Natera’s molecular residual disease (MRD) test.

IMvigor011, sponsored by Genentech, is a Phase III trial evaluating high-risk MIBC patients. Those who test MRD-positive are randomized to atezolizumab vs. placebo, while MRD-negative patients undergo radiographic imaging.

The analysis evaluates outcomes in 171 MRD-negative MIBC patients, showing high overall and disease-free survival rates. This suggests that MRD-negative patients may not require adjuvant treatment.

John Simmons, VP of BioPharma at Natera, highlights the trial’s potential to personalize treatment decisions. Natera aims to submit Signatera as a companion diagnostic for FDA approval.

These findings build on the IMvigor010 trial, indicating significant benefits for MRD-positive patients receiving adjuvant immunotherapy. Natera has already submitted Signatera for FDA approval as a companion diagnostic.

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