On October 20, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

IMvigor011 prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive based on serial testing up to 7 times in the first year post-cystectomy.

Study highlights:

761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo.

Signatera-positive patients treated with atezolizumab experienced a >2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo (HR: 0.64; P=0.005). Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS (median of 32.8 months vs. 21.1 months; HR: 0.59; P=0.01).

Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk (DFS of 95.4% at 1 year and 88.4% at 2 years). OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity.
"IMvigor011 has delivered practice-changing evidence in bladder cancer," said Professor Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology, chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Patients who tested Signatera-positive clearly benefitted from atezolizumab, while those who remained Signatera-negative had excellent outcomes without additional treatment. This is the most impactful data to date for personalized MRD testing, reinforcing Signatera’s predictive abilities to transform care."

"This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimizing overtreatment and allowing therapy to be precisely guided by Signatera results," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumor types."

Data from IMvigor011 will support Natera’s premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

(Press release, Natera, OCT 20, 2025, View Source [SID1234656851])