Natera Announces Positive Results From IMvigor011 Phase III Study In Muscle-Invasive Bladder Cancer

(RTTNews) - Cell-free DNA testing company Natera, Inc. (NTRA) announced Friday an analysis from the IMvigor011 study that was presented at the European Association of Urology (EAU) Congress 2024 in Paris, France.

The analysis evaluates 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.

Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy.

Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq) vs. placebo.

Patients who remain Signatera-negative at completion of the testing window are not randomized but continue to undergo radiographic imaging thereafter.

The analysis presented at the EAU Congress evaluated clinical outcomes in 171 high-risk MIBC patients who entered screening for IMvigor011 and remained MRD-negative during the surveillance window.

The overall survival (OS) rates were 100% at 12 months and 98% at 18 months, in patients who remained serially MRD-negative. The disease-free survival (DFS) rates were 92% at 12 months and 88% at 18 months, in patients who remained serially MRD-negative.