New Signatera(TM) Data to be Presented at the 2020 ESMO IO Congress from the Phase III IMvigor010 Trial
SAN CARLOS, Calif., Dec. 9, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that new data will be presented on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in an oral presentation on December 10, 2020 at the 2020 European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress. The abstract is available to view here.
The oral presentation will report results from a prospective circulating tumor DNA (ctDNA) analysis of 581 muscle invasive urothelial carcinoma (MIUC) patients who participated in IMvigor010, an open-label, global, randomized and controlled Phase III study that evaluated adjuvant treatment with the PD-L1 inhibitor atezolizumab compared with observation. Results at an interim analysis show that patients who were ctDNA-positive after surgery (37%) had an increase in overall survival (OS) in the treatment arm, with a median of 25.8 months with Tecentriq, compared with 15.8 months for observation (HR=0.59; 95% CI: 0.41–0.86), while those patients who were ctDNA-negative after surgery derived no benefit. The study also shows that ctDNA clearance was higher in the treatment arm vs. the observation arm (p=0.0048).
"In this study, we show that personalized ctDNA analysis is highly accurate not only for identifying molecular residual disease, but also for predicting better outcomes with immune therapy," said Thomas Powles, M.D., Professor, Barts Cancer Institute, and Principal Investigator of the study. "This opens new avenues for patient selection in the future and is an important step in the drive towards personalized cancer therapy."
"We are honored to partner with Genentech on this groundbreaking study," said Alexey Aleshin, M.D., Natera's Senior Medical Director of Oncology. "This randomized Phase III study demonstrates for the first time, unequivocally, that Signatera can identify which patients are likely to benefit from adjuvant therapy and which are unlikely to benefit. It also highlights the significance of ctDNA clearance as an early endpoint for the evaluation of drug efficacy."
Details about the presentation are as follows:
Presentation #10 | Presenter: Thomas Powles, M.D. | Date and time: Dec 10, 13:50 - 14:02 CET
Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy
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 clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. 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. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it 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.
Natera is a pioneer and global leader in cell-free DNA testing. 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 an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in 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.
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.
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