Pivotal clinical trial aims to establish a new standard of care for stage II and III colon cancer patients AUSTIN, Texas, Sept. 7, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA) a leader in transforming care through genetic and cell-free DNA testing, today announced an agreement with NRG Oncology, a National Cancer Institute (NCI)-funded group, to use the Signatera personalized molecular residual disease (MRD) test in NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US), a prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early stage colon cancer. The study will enroll approximately 2,000 patients with stage II or III colon cancer after resection. Patients identified as MRD-negative by Signatera will be randomized to receive either standard-of-care (SOC) adjuvant chemotherapy or observation unless circulating tumor DNA (ctDNA) is subsequently detected during surveillance. Patients identified as MRD-positive will be randomized to receive SOC chemotherapy or an intensified regimen with mFOLFIRINOX. The study's primary endpoint is to compare disease-free survival in (1) MRD-negative patients between immediate vs. delayed adjuvant chemotherapy, and (2) MRD-positive patients between SOC vs. intensified adjuvant chemotherapy. The CIRCULATE-US study is part of an international collaboration announced at the ESMO 2019 conference to tailor adjuvant chemotherapy using emerging ctDNA technologies. CIRCULATE-Japan, which also uses Signatera to drive adjuvant treatment escalation and de-escalation in patients with resected colon cancer, has already reported promising data1,2 at the ASCO and ESMO GI conferences this year. "Current standard-of-care guidelines recommend adjuvant chemotherapy for all stage III and high-risk stage II patients, when in reality, only 20%-25%3 of these patients receive any benefit, while everyone is at risk of having side effects,'' said Arvind Dasari, M.D., M.S., principal study investigator and associate professor, MD Anderson Cancer Center. "We are pleased to have selected Natera for this study based on the strength and quality of their evidence. We believe Signatera will help us expand the role of ctDNA in identifying patients who are likely to benefit from chemotherapy and those who can be spared." "We are proud to partner with NRG Oncology on this innovative study that is unlikely to be repeated in the U.S.," said Alexey Aleshin, M.D., Natera's VP of medical affairs, oncology. "We believe the CIRCULATE-US study could provide definitive evidence to further strengthen Signatera as a potentially predictive biomarker for the management of early stage colon cancer and, in the process, improve outcomes for tens of thousands of patients in this country." 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 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. About NRG Oncology NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of people with cancer. As one of the five research groups in the National Cancer Institute (NCI) funded National Clinical Trials Network (NCTN), NRG Oncology carries out clinical trials on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology's extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites worldwide, primarily in the United States and Canada. NRG Oncology is a non-profit research organization, funded mainly through grants from the NCI. 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 be repeated in later studies or 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. ContactsInvestor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com References https://www.natera.com/company/news/natera-to-present-clinical-data-from-largest-prospective-mrd-guided-trial-in-colorectal-cancer-at-the-2021-asco-annual-meeting/ https://www.natera.com/company/news/new-results-from-the-landmark-prospective-circulate-trial-expand-clinical-utility-of-the-signatera-mrd-test-in-colorectal-cancer/ Kuebler JP, Wieand HS, O'Connell MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198-2204 View original content to download multimedia:https://www.prnewswire.com/news-releases/nateras-signatera-test-selected-for-nrg-oncologys-landmark-circulate-us-study-of-mrd-guided-treatment-in-stage-ii-iii-colon-cancer-301370049.html SOURCE Natera, Inc.
AUSTIN, Texas, Sept. 7, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA) a leader in transforming care through genetic and cell-free DNA testing, today announced an agreement with NRG Oncology, a National Cancer Institute (NCI)-funded group, to use the Signatera personalized molecular residual disease (MRD) test in NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US), a prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early stage colon cancer. The study will enroll approximately 2,000 patients with stage II or III colon cancer after resection. Patients identified as MRD-negative by Signatera will be randomized to receive either standard-of-care (SOC) adjuvant chemotherapy or observation unless circulating tumor DNA (ctDNA) is subsequently detected during surveillance. Patients identified as MRD-positive will be randomized to receive SOC chemotherapy or an intensified regimen with mFOLFIRINOX. The study's primary endpoint is to compare disease-free survival in (1) MRD-negative patients between immediate vs. delayed adjuvant chemotherapy, and (2) MRD-positive patients between SOC vs. intensified adjuvant chemotherapy. The CIRCULATE-US study is part of an international collaboration announced at the ESMO 2019 conference to tailor adjuvant chemotherapy using emerging ctDNA technologies. CIRCULATE-Japan, which also uses Signatera to drive adjuvant treatment escalation and de-escalation in patients with resected colon cancer, has already reported promising data1,2 at the ASCO and ESMO GI conferences this year. "Current standard-of-care guidelines recommend adjuvant chemotherapy for all stage III and high-risk stage II patients, when in reality, only 20%-25%3 of these patients receive any benefit, while everyone is at risk of having side effects,'' said Arvind Dasari, M.D., M.S., principal study investigator and associate professor, MD Anderson Cancer Center. "We are pleased to have selected Natera for this study based on the strength and quality of their evidence. We believe Signatera will help us expand the role of ctDNA in identifying patients who are likely to benefit from chemotherapy and those who can be spared." "We are proud to partner with NRG Oncology on this innovative study that is unlikely to be repeated in the U.S.," said Alexey Aleshin, M.D., Natera's VP of medical affairs, oncology. "We believe the CIRCULATE-US study could provide definitive evidence to further strengthen Signatera as a potentially predictive biomarker for the management of early stage colon cancer and, in the process, improve outcomes for tens of thousands of patients in this country." 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 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. About NRG Oncology NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of people with cancer. As one of the five research groups in the National Cancer Institute (NCI) funded National Clinical Trials Network (NCTN), NRG Oncology carries out clinical trials on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology's extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites worldwide, primarily in the United States and Canada. NRG Oncology is a non-profit research organization, funded mainly through grants from the NCI. 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 be repeated in later studies or 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. ContactsInvestor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com References https://www.natera.com/company/news/natera-to-present-clinical-data-from-largest-prospective-mrd-guided-trial-in-colorectal-cancer-at-the-2021-asco-annual-meeting/ https://www.natera.com/company/news/new-results-from-the-landmark-prospective-circulate-trial-expand-clinical-utility-of-the-signatera-mrd-test-in-colorectal-cancer/ Kuebler JP, Wieand HS, O'Connell MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25:2198-2204 View original content to download multimedia:https://www.prnewswire.com/news-releases/nateras-signatera-test-selected-for-nrg-oncologys-landmark-circulate-us-study-of-mrd-guided-treatment-in-stage-ii-iii-colon-cancer-301370049.html SOURCE Natera, Inc.