Natera's Signatera MRD Test Shows Promise in Guiding Bladder Cancer Treatment at ESMO 2025
Key Insights
Natera will present 14 studies at ESMO 2025, including six oral presentations highlighting Signatera's expanding role in molecular residual disease testing across multiple cancer types.
The IMvigor011 trial demonstrates Signatera's ability to predict disease-free survival and overall survival benefits from adjuvant atezolizumab in muscle-invasive bladder cancer (search) patients.
CheckMate 274 trial results show that Signatera-positive patients treated with nivolumab had more than doubled disease-free survival compared to placebo (7.4 vs 2.8 months).
Natera, Inc. will showcase groundbreaking research on molecular residual disease (MRD) testing at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, October 17-21, 2025. The company announced 14 studies featuring its Signatera technology, with six oral presentations reinforcing its leadership position in MRD testing across multiple cancer types.
Breakthrough Results in Bladder Cancer Treatment
The IMvigor011 trial, sponsored by Genentech, has earned selection for a Presidential Symposium on October 20. This phase III study represents the first prospective trial in muscle-invasive bladder cancer (search) (MIBC) to utilize a bespoke MRD-guided approach. The presentation will include additional data on Signatera's ability to predict disease-free survival (DFS) and overall survival (OS) benefit from adjuvant Tecentriq® (atezolizumab) in MIBC patients, building on positive topline results announced in August.
Complementing these findings, the CheckMate 274 trial results demonstrate significant clinical impact. This phase III study randomized high-risk MIBC patients 1:1 to receive Opdivo® (nivolumab) or placebo for up to one year of adjuvant treatment. The results revealed that DFS for Signatera-positive patients treated with nivolumab more than doubled compared to placebo (7.4 months vs 2.8 months; HR: 0.35). Notably, no significant improvement in DFS was observed with nivolumab among Signatera-negative patients.
Expert Perspectives on Clinical Impact
"Across multiple different Phase 3 trials, we've now shown how Signatera MRD can help identify patients with bladder cancer who are most likely to benefit from adjuvant immunotherapy," said Matthew Galsky, M.D., Lillian and Howard Stratton Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at the Tisch Cancer Center. "These key studies are building a powerful foundation for bespoke MRD to guide different forms of treatment, improve outcomes for patients with bladder cancer and change medical practice."
Expanding Applications Across Cancer Types
The ESMO presentations extend beyond bladder cancer, encompassing studies in colorectal cancer (search), breast cancer (search), lung cancer, and other solid tumors. Additional oral presentations include results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera's early cancer detection program.
"We are proud to showcase the breadth of research using Signatera at this year's ESMO Congress, including oral presentations across bladder, colorectal, breast, and other cancers," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "The diversity of these datasets underscores the growing impact of bespoke MRD assessment in reshaping how we detect and monitor cancer, providing tools to personalize treatment recommendations in oncology–with the ultimate goal of improving outcomes for patients."
Comprehensive Research Portfolio
The 14 presentations span multiple cancer types and treatment approaches, including studies on treatment response monitoring in non-small cell lung cancer (search), early treatment response evaluation in endometrial and ovarian cancers, and recurrence detection in renal cell carcinoma (search). The research portfolio also includes investigations into early cancer detection screening tests and treatment de-escalation strategies in HER2-positive metastatic breast cancer (search).
Natera's technology is supported by more than 300 peer-reviewed publications demonstrating excellent performance. The company operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California.