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FX.co ★ Natera Announces Positive Results From IMvigor011 Phase III Study In Muscle-Invasive Bladder Cancer

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typeContent_19130:::2024-04-05T12:33:00

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

Natera, Inc., a company specializing in cell-free DNA testing, recently shared an analysis from the IMvigor011 study at the 2024 European Association of Urology Congress in Paris, France. This analysis examined outcomes for patients with muscle-invasive bladder cancer (MIBC) who consistently tested negative using Signatera, Natera's personalized molecular residual disease (MRD) test.

Supported by Genentech, part of the Roche group, the IMvigor011 study is a global, double-blind, randomized Phase III trial. It involves the ongoing testing of high-risk MIBC patients using Signatera, for a period up to 12 months following cystectomy.

Any patients who, at any time within the 12-month surveillance window, test positive for MRD using Signatera are then randomly assigned to either the anti-PDL1 atezolizumab (Tecentriq) or a placebo. Those patients who consistently test negative at the end of the testing window are not assigned randomly but continue with radiographic imaging thereafter.

The analysis discussed at the EAU Congress looked at clinical outcomes for 171 high-risk MIBC patients who stayed MRD-negative during the surveillance window after being screened for IMvigor011. The overall survival rates were 100% at 12 months and 98% at 18 months among patients who consistently tested MRD-negative. The disease-free survival rates also remained high, at 92% at 12 months and 88% at 18 months, in these same patients.

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