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Clinical case studies demonstrate the performance of the Signatera™ test in cancer patients receiving immunotherapy
SAN CARLOS, Calif., Nov. 10, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced it will present new immunotherapy data on its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, taking place November 9-14, 2020.
Natera will present four posters demonstrating the ability of Signatera to monitor response to immunotherapy in colorectal and breast cancer.
"Tumor-informed circulating tumor DNA tests have broad clinical utility across cancer types," said Georges Azzi, MD, oncologist at Holy Cross Health in Ft. Lauderdale, Florida and co-author of one of the posters presented. "I am excited to partner with Natera to further explore early indications of treatment response, or lack thereof, using this novel technology."
"We have consistently demonstrated the clinical utility of MRD testing with Signatera to help patients detect recurrence earlier, and we are now seeing evidence of Signatera's ability to effectively monitor immunotherapy treatment," said Alexey Aleshin, MD, Natera's Senior Medical Director of Oncology. "The studies we are presenting at SITC showcase Signatera's broadened capability to evaluate immunotherapy treatment response, an area in which there is a significant unmet need for more optimal diagnostic tools."
Details about the abstracts are as follows:
Abstract #23 | Poster Presentation
Presenter: Pashtoon Kasi, MD, MS
Circulating tumor DNA (ctDNA) serial analysis during progression on PD-1 blockade and later CTLA-4 rescue in patients with mismatch repair deficient metastatic colorectal cancer
A case series of three patients with mismatch repair deficient (dMMR), high microsatellite instability metastatic colorectal cancer (CRC), who progressed on PD-1 inhibitor pembrolizumab and were being treated with CTLA-4 inhibitors (nivolumab and ipilimumab). All patients were monitored with radiological imaging and serial ctDNA assessments using Signatera. ctDNA levels were corroborated by imaging in all cases and predicted tumor responses weeks ahead of imaging, supporting the use of ctDNA as a dynamic biomarker for response to immunotherapy.
Abstract #24 | Poster Presentation
Presenter: Pashtoon Kasi, MD, MS
Utility of tumor-informed molecular residual disease assays in patients with complete response to immune checkpoint blockade
Data regarding neoadjuvant usage of immunotherapy pertaining to mismatch repair deficient tumors is limited to-date. This poster describes two patients with advanced, non-metastatic dMMR tumors undergoing immune checkpoint blockade (ICB) therapy. Both patients achieved robust and dramatic responses to ICB therapy, with complete clearance of ctDNA and no evidence of residual disease radiologically, supporting the clinical decision to defer surgery and radiation. These data highlight a potential use of ctDNA-based MRD testing to help inform "watch & wait" approaches.
Abstract #25 | Poster Presentation
Presenter: Georges Azzi, MD
Line of therapy adjustment in a patient with advanced triple-negative breast cancer (TNBC) by using personalized ctDNA test for treatment response monitoring
A case study of a patient with advanced TNBC whose clinical course was tracked using ctDNA and radiologic imaging. After surgery, the patient tested positive for MRD using Signatera, but negative when assessed using a tumor-naive assay. Serial ctDNA analysis over the course of the patient's treatment enabled detection of lack of response and acquired resistance to therapy as much as 80 days earlier compared to imaging.
Abstract #26 | Poster Presentation
Presenter: Charles J. Schneider, MD, FACP
ctDNA clearance and radiographic resolution of lymph node metastasis in a patient with metastatic microsatellite stable colorectal cancer on immunotherapy
A case study of a patient with metastatic CRC with high tumor mutational burden (TMB) and CEA-low phenotype. The patient was MRD positive following initial surgical resection of the metastatic lesion, with ctDNA continuing to rise as a result of lymph node involvement. Upon receiving two rounds of immunotherapy, the patient showed complete clearance of ctDNA, correlating with radiologic resolution of metastatic disease. This suggests that ctDNA can serve as a dynamic biomarker of disease status, which may be more useful for monitoring treatment response, regardless of CEA expression.
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, 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 screening tests, or regarding the benefits of our screening 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
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