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Natera Announces Launch of ABCSG 61 (“TEODOR”), a Randomized Controlled Trial of Signatera™ in Early-Stage Breast Cancer

By: via Business Wire

Study utilizes Signatera to identify HR+, HER2-negative breast cancer patients for de-escalation of neoadjuvant chemotherapy

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the launch of the TEODOR trial (Neoadjuvant TrEatment Optimization driven by ctDNA and endOcrine Responsiveness). TEODOR is a Phase II, multicenter, randomized controlled trial (RCT) that aims to replace chemotherapy with endocrine therapy prior to surgery for a subset of women with hormone receptor-positive (HR+), HER2-negative breast cancer, who are endocrine responsive and test negative with Signatera.

Sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), TEODOR expects to enroll approximately 250 patients across 15 sites in Austria. Previous studies have demonstrated that patients who test Signatera-negative at diagnosis and then receive chemotherapy have excellent outcomes, with risk of recurrence at less than 5%. In an effort to reduce pre-operative chemotherapy, which can carry significant side effects, this study is designed to evaluate the efficacy of endocrine therapy compared to chemotherapy in patients who are Signatera-negative.

After a four-week course of endocrine therapy, patients who are Signatera-negative and show a favorable endocrine sensitivity as measured by the Ki-67 proliferation index will be randomized to receive either additional endocrine therapy or chemotherapy. The primary endpoint of the study is the rate of neoadjuvant therapy response, assessed via pathological complete response (pCR) and modified Preoperative Endocrine Prognostic Index (PEPI) score across the endocrine therapy and chemotherapy arms of the trial. Secondary endpoints include long-term outcomes such as breast cancer recurrence and overall survival.

“TEODOR is designed to examine whether we can use endocrine responsiveness and ctDNA status to optimize systemic therapy in the neoadjuvant setting,” said ABCSG President, Michael Gnant, M.D., FACS, FEBS, who serves as professor of surgery, Comprehensive Cancer Center, Medical University of Vienna, and principal investigator of the TEODOR trial. “This study marks a critical step toward more personalized medicine, leveraging the latest technologies to improve patient care.”

“With the TEODOR trial, our goal is to identify patients who may be able to safely forgo chemotherapy,” said Angel Rodriguez, M.D., medical director of oncology at Natera. “We are proud to collaborate with ABCSG on this important trial, and we hope this study will support the role of Signatera in guiding neoadjuvant therapy in breast cancer.”

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.

About ABCSG

The ABCSG (Austrian Breast & Colorectal Cancer Study Group) is Austria’s largest and best-known academic research organization, successfully conducting international clinical trials on breast and colorectal cancer — and, since 2013, also on pancreatic cancer. In addition, ABCSG is increasingly active in translational research. Our goal is to standardize diagnostics, treatment, and follow-up care throughout Austria and to offer patients the best and most up-to-date therapies. Since 1984, approximately 29,000 patients have participated in ABCSG studies worldwide. Multidisciplinarity is key to our global success and has helped improve cure rates and survival. Our clinical trials and translational research projects are conducted transparently and are monitored at every stage by ethics committees, regulatory authorities, and our highly professional and dedicated ABCSG team.

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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