Natera : Phase 3 Trial Results Show Signatera-Guided Therapy Improves Survival In Bladder Cancer

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(RTTNews) - Natera Inc. (NTRA) announced results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera, Natera's personalized molecular residual disease (MRD) test, can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq), leading to improved disease-free survival (DFS) and overall survival (OS) in patients with MIBC.

Sponsored by Genentech, a member of the Roche Group, the IMvigor011 trial was designed to address the challenge of identifying patients who would benefit most from adjuvant immunotherapy. The study prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive through serial testing conducted up to seven times during the first year following cystectomy.

A total of 761 patients were enrolled in surveillance, with approximately half testing Signatera-positive. Of these, 250 patients were randomized to receive either atezolizumab or placebo. Signatera-positive patients treated with atezolizumab experienced more than a twofold increase in median DFS compared to those receiving placebo (9.9 months vs. 4.8 months). Additionally, these patients saw a statistically significant and clinically meaningful improvement in OS, with a median of 32.8 months versus 21.1 months for placebo (HR: 0.59; P=0.01).

Signatera-negative patients demonstrated excellent outcomes without adjuvant immunotherapy. Those who remained persistently Signatera-negative during surveillance had a very low recurrence risk, with DFS rates of 95.4% at one year and 88.4% at two years. Their OS outcomes were also remarkably strong, allowing them to avoid unnecessary treatment and potential toxicity.

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