Natera Presents New Colorectal and Breast Cancer Data at ESMO 2022, Highlighting Signatera's Ability to Inform Treatment Decisions in the Adjuvant and Neoadjuvant Settings

Data from the largest real-world MRD study to date in resectable colorectal cancer reinforces the findings from the recent CIRCULATE-Japan study

AUSTIN, Texas, Sept. 12, 2022 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, at the 2022 European Society for Medical Oncology (ESMO) World Congress, taking place September 9-13 in Paris, France.

Signatera data was presented in 4 abstracts, including both oral and poster presentations. These include results from a real-world study on colorectal cancer (CRC) patients as well as an early readout from the BELLINI trial that highlights how circulating tumor DNA (ctDNA) dynamics can help inform neoadjuvant treatment decision-making in hormone receptor negative, HER2 negative (triple-negative) breast cancer (TNBC). The key highlights are below:

Abstract # 1828 | Late-Breaking Oral Presentation | Presenter: Marleen Kok

Nivolumab and ipilimumab in early stage triple negative breast cancer (TNBC) with tumor-infiltrating lymphocytes (TILs): first results from the BELLINI trial

This study evaluates the potential clinical utility of ctDNA in assessing the response to neoadjuvant immunotherapy in patients with early stage (I-II) TNBC. Thirty patients were treated with two cycles of the immune checkpoint inhibitor (ICI) nivolumab, alone or in combination with ipilimumab, prior to the start of neoadjuvant chemotherapy. Response to ICIs was evaluated radiographically, as well as through the analysis of ctDNA dynamics. All of the patients who achieved partial response by imaging presented with 50-100% reduction in ctDNA levels compared to pretreatment, while increasing or stable ctDNA levels were observed in non-responders.

"The BELLINI trial supports MRD testing for early, reliable immunotherapy response monitoring in the neoadjuvant TNBC setting," said Dr. Minetta Liu, Natera's chief medical officer of oncology. "We are very encouraged by the data generated through our collaboration with Dr. Kok and colleagues, and we look forward to ongoing work to push the boundaries of chemotherapy de-escalation."

Abstract # 319MO | Mini Oral Presentation | Presenter: Stacey A. Cohen

Real world monitoring of circulating tumor DNA reliably predicts cancer recurrence in patients with resected stages I-III colorectal cancer

In this retrospective analysis of a real-world cohort of 16,347 patients with early stage colorectal cancer, MRD status was assessed using the Signatera test after surgery and during surveillance. Complete clinical information was available for a subset of 417 patients, and showed that postoperative MRD-positive status was significantly associated with inferior recurrence-free survival. Patients who were MRD-negative showed no significant benefit from adjuvant chemotherapy, regardless of other risk factors such as stage, age or microsatellite instability status.

"The results from this large, real-world dataset reinforce those from the CIRCULATE-Japan study presented earlier this year, and provide further evidence for the potential value of MRD testing in the clinic," said the study's principal investigator, Dr. Stacey Cohen of the Fred Hutchinson Cancer Center. "Incorporating MRD testing into the standard of care for CRC may better identify the patients with a high risk of recurrence – enabling timely intervention, while sparing those who would not benefit from unnecessary treatment."

Abstract # 1649P | Poster Presentation | Presenter: Danica Vodopivec Kuri

A proof-of-concept study for detecting ctDNA in rare thyroid cancers

Abstract # 728O | Oral Presentation | Presenter: Omid Hamid

Results from phase I dose escalation of IMC-F106C, the first PRAME × CD3 ImmTAC bispecific protein in solid tumors

Signatera dynamics used to assess therapy response across multiple tumor types.

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 Signatera's 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 assess how much cancer is left in the body, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA 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 validated by more than 100 peer-reviewed publications that demonstrate high accuracy. 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, or coverage and reimbursement determinations from third-party 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: Brian Symmons, SVP of Marketing and Corporate Affairs, Natera, Inc., pr@natera.com

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SOURCE Natera, Inc.