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Natera to Present New Immunotherapy Monitoring Data at SABCS 2020
Two new studies in breast cancer demonstrate potential of Natera's technology to predict response to neoadjuvant immunotherapy and discover new treatment resistance mechanisms

SAN CARLOS, Calif., Dec. 8, 2020 /PRNewswire/ -- Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new data on its personalized and tumor-informed circulating tumor DNA (ctDNA) assay, Signatera,™ at the 2020 virtual San Antonio Breast Cancer Symposium (SABCS) taking place December 8-11, 2020

Natera will present two posters: one from the I-SPY2 Trial describing Signatera's performance as a predictive biomarker for response to neoadjuvant immunotherapy, and the other from the Beyond BRCA study describing Natera's plasma-based whole exome analysis as a tool for tracking clonal evolution and discovering new treatment resistance mutations.

Details about the presentations are as follows:

Poster #PD9-02 | Spotlight Poster Discussion
Presenter: Mark Jesus M. Magbanua, Ph.D.
Date: Dec 10, 2020 | 3:30 PM to 4:45 PM CT

Personalized ctDNA as a predictive biomarker in high-risk early stage breast cancer treated with neoadjuvant chemotherapy (NAC), with or without pembrolizumab

A study from the prospective, randomized I-SPY2 Trial exploring the predictive value of personalized ctDNA analysis, performed by Natera, in patients with early-stage breast cancer undergoing either standard NAC or NAC in combination with the immune checkpoint inhibitor pembrolizumab. Early clearance of ctDNA (three weeks after initiation of treatment) is significantly associated with achieving pathological complete response, and may serve as an early surrogate marker for response to therapy. Persistent presence of ctDNA after completion of NAC, but prior to surgery, is strongly correlated with poor disease-free survival.

"Just last week, the I-SPY investigators published a paper in Annals of Oncology validating Signatera's performance in neoadjuvant treatment monitoring for patients with early-stage breast cancer," said Angel Rodriguez, M.D., Medical Director at Natera. "This new study presented at SABCS follows a different cohort of I-SPY2 patients who received NAC in combination with immunotherapy. The results from this new cohort further validate the initial finding that Signatera can be a powerful tool for neoadjuvant treatment response monitoring, regardless of the type of therapy, and can complement existing tools, such as pathology and imaging, to optimize decisions around the escalation or de-escalation of treatment." 

Poster #PD10-12 | Spotlight Poster Discussion
Presenter: Joshua J. Gruber, M.D., Ph.D.
Date: Dec 11, 2020 | 1:00 PM to 2:15 PM CT

Genomic analysis from the Talazoparib Beyond BRCA clinical trial: homologous recombination deficiency (HRD) scores, loss-of-heterozygosity and mutations in non-BRCA 1/2 mutant tumors

A poster on the genomic characterization of treatment response and resistance to the PARP1 inhibitor, talazoparib, in non-BRCA 1/2 mutant tumors with mutations in other HRD-associated genes. Plasma-based whole exome sequencing of ctDNA, performed by Natera, provides a comprehensive view of tumor evolution over the course of treatment, wherein responders and nonresponders show distinct patterns, leading to the identification of novel mutations responsible for acquired resistance to talazoparib treatment.

"Drug resistance remains a significant challenge in the management of breast cancer," said Joshua J. Gruber, M.D., Ph.D., medical oncologist at Stanford University Medical Center and the lead author of the Beyond BRCA study. "The ability to non-invasively characterize the molecular evolution of tumors during treatment using ctDNA can guide further investigation of treatment resistance."

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 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.

About Natera
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, cancer researchers, biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com.

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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, whether the results of clinical or other studies will support the use of our product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, our expectations regarding the reliability, accuracy and performance of our tests, or regarding 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: Paul Greenland, VP of Corporate Marketing, Natera, Inc., pr@natera.com

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© Natera 2021. All Rights Reserved. The tests described on this site were developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). The tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.