Six oral presentations highlight Signatera’s expanding role across solid tumors, including definitive predictive data in adjuvant bladder cancer

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that 14 studies featuring its technology will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 17–21 in Berlin, Germany. The slate includes six oral presentations, reinforcing Natera’s position as a leader in molecular residual disease (MRD) testing across multiple cancer types.

Bladder Cancer Highlights

The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, has been selected for a Presidential Symposium on October 20. With positive topline results announced in August, this oral 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 muscle-invasive bladder cancer (MIBC). IMvigor011 is the first prospective, phase III study in MIBC to be read out that uses a bespoke MRD-guided approach.

MRD analysis from the Phase 3 CheckMate 274 trial will also be shared in an oral presentation on October 17. CheckMate 274 randomized high-risk MIBC patients 1:1 to Opdivo® (nivolumab) or placebo for ≤ 1 year of adjuvant treatment. The results showed 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). In contrast, no significant improvement in DFS was observed with the use of nivolumab among Signatera-negative patients.

Additional ESMO Data

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.

“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.”

“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.”

Full list of presentations featuring Natera’s technology at ESMO includes:

October 17, 2:50 PM CEST | 3068O (Oral Presentation)

Presenter: Matthew D. Galsky, M.D.

Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274

October 17, 4:40 PM CEST | LBA 112 (Mini Oral Presentation)

Presenter: Andrea Necchi, M.D.

Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

October 18, 9:00 AM CEST | 185eP

Presenter: Michael Galo

Treatment response using a tumor-informed circulating DNA test (TIctDNA) comparing with radiologic outcomes in non-small cell lung cancer (NSCLC)

October 18, 12:00 PM CEST | 1132P

Presenter: Floortje Backes, M.D.

Utility of circulating tumor DNA (ctDNA) dynamics for evaluating early treatment response in patients with recurrent/metastatic endometrial (rEC) and recurrent/platinum-resistant ovarian cancer (rPROC)

October 18, 12:00 PM CEST | 2609P

Presenter: Arnab Basu, MBBS, MPH, FACP, M.D.

Clinical Performance of a Tumor-Informed Whole Genome-Based (WGS) ctDNA Assay for Recurrence Detection and Treatment Response Monitoring in Localized and Advanced/Metastatic Renal Cell Carcinoma (RCC)

October 19, 12:00 PM CEST | 764P

Presenter: Masaaki Miyo, M.D., Ph.D.

Association of ultrasensitive whole genome sequencing (WGS)-based tumor-informed molecular residual disease (MRD) detection with lymph node metastasis (LNM) after local excision of pathological T1 colorectal cancer: Results from DENEB, a CIRCULATE-Japan GALAXY substudy

October 19, 2:45 PM CEST | 734MO (Mini Oral Presentation)

Presenter: Yoshiaki Nakamura, M.D., Ph.D.

Performance of a blood-based, early cancer detection (ECD) screening test for colorectal cancer (CRC) in cell-free (cf)DNA

October 19, 2:50 PM CEST | 732MO (Mini Oral Presentation)

Presenter: Emerick Osterlund, M.D., Ph.D.

Circulating tumor DNA (ctDNA) clearance and correlation with outcome in the INTERCEPT colorectal cancer (CRC) study

October 19, 12:00 PM CEST | 823P

Presenter: Kozo Kataoka, M.D.

A Phase II Study of mFOLFOXIRI Following Metastasectomy in Oligometastatic Colorectal Cancer: (FANTASTIC)

October 19, 3:40 PM CEST | LBA 31 (Oral Presentation)

Presenter: Yara L. Verschoor

Neoadjuvant immunotherapy induces immune activation and responses in MMR-proficient colon cancers

October 20, 12:00 PM CEST | 620TiP

Presenter: Benjamin Verret, M.D.

HEROES: De-escalation of anti-HER2 therapies in HER2-positive metastatic breast cancer with long-term persistent response and undetectable minimal residual disease in circulating tumor DNA

October 20, 12:00 PM CEST | 354P

Presenter: Adrian Lee, Ph.D.

Hormonal and immune mediators of resistance to primary endocrine therapy

October 20, 12:00 PM CEST | 336P

Presenter: Arielle J. Medford, M.D.

Circulating tumor DNA detection in stage 1 HER2 positive and triple negative breast cancer (SAFE-DE)

October 20, 4:30 PM CEST | LBA 8 (Oral Presentation)

Presenter: Thomas B. Powles, MBBS, MRCP, M.D.

IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

Notes

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

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