Data to be featured in Presidential Symposium at ESMO

Signatera™ changes the paradigm by expanding the adjuvant decision window, with up to 7 tests in the first year post-surgery, enabling effective initiation of treatment only after a positive test result, and allowing patients with persistently negative results to avoid unnecessary treatment

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced 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) Congress.

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.

References

1. National Comprehensive Cancer Network, Bladder Cancer. NCCN Clinical practice guidelines in oncology (NCCN Guidelines). Version 4.2021.
2. Gakis G. Management of Muscle-invasive Bladder Cancer in the 2020s: Challenges and Perspectives. Eur. Urol. Focus. 2020;6(4):632-638.
3. Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19(3):666–675. doi:10.1200/JCO.2001.19.3.666
4. Yafi FA, Aprikian AG, Chin JL, et al. Contemporary outcomes of 2,287 patients with bladder cancer treated with radical cystectomy: a Canadian multicentre experience. BJU Int. 2011;108(4):539–545. doi:10.1111/j.1464-410X.2010.09912.x

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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