Nature Journal Publishes Prospective, Randomized Study Validating Signatera® for Prediction of Immunotherapy Benefit

AUSTIN, Texas, June 16, 2021 /PRNewswire/ -- Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced the publication of a new study in Nature, validating the ability of its personalized and tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, to predict outcomes with immunotherapy in a randomized clinical trial. The study, which can be found here, is Signatera's 12th peer-reviewed publication and is the first publication that shows the predictive capabilities of a molecular residual disease (MRD) test in a large, randomized, multi-center study.

"In this study, we show that personalized ctDNA analysis is highly accurate not only for identifying molecular residual disease, but also for predicting treatment outcomes with immunotherapy," said Thomas Powles, M.D., professor, Barts Cancer Institute, and first author of the study. "This opens new avenues for patient stratification, an important step in the drive towards personalized cancer therapy."

This data comes on the heels of Natera's announcement of the prospective Phase III IMvigor011 trial, sponsored by Genentech. The study uses Signatera as a companion diagnostic to evaluate the safety and efficacy of adjuvant treatment with atezolizumab (Tecentriq)® in patients with muscle-invasive urothelial carcinoma (MIUC) who are MRD-positive after surgery.

The paper reports results from a prospective ctDNA analysis of 581 MIUC patients who were enrolled in IMvigor010, a Phase III randomized study that evaluated adjuvant treatment with the PD-L1 inhibitor atezolizumab versus observation. While the intent-to-treat all-comer analysis failed to meet its primary endpoint, the ctDNA-positive subset (37%) had significantly improved clinical outcomes upon treatment, compared to observation alone. The median overall survival in Signatera-identified ctDNA-positive patients treated with atezolizumab was 25.8 months compared to 15.8 months in those under observation alone. ctDNA status was assessed after surgery and prior to the start of therapy, and at week six of the treatment regimen.

Key findings from the study include:

• ctDNA-positive patients after surgery (37%) derived significant treatment benefit and had a 41% improvement in overall survival (HR 0.59)
• ctDNA-negative patients after surgery (63%) derived no treatment benefit
• The rate of ctDNA clearance was higher in the treatment arm (18.8%) compared to the observation arm (3.8%), indicating that ctDNA status/clearance can serve as an early indicator of treatment response
• Patients who responded to atezolizumab had significantly different RNA signatures from the patients who did not respond

"These findings have significant implications for patient care, the cost of care and how we collectively approach the design of clinical trials in the adjuvant setting," said Alexey Aleshin, M.D., Natera's vice president of medical affairs, oncology and co-author of the study. "For the first time, we have definitive evidence that Signatera can identify patients who will benefit from immunotherapy and monitor response in real time. We believe this may provide immediate clinical utility to better identify patients likely to benefit from adjuvant therapy in routine clinical practice."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, 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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 [email protected]

SOURCE Natera, Inc.

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