Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced a collaborative agreement with Mass General Cancer Center (MGCC) of Massachusetts General Hospital, related to an investigator-initiated multi-center, Phase II randomized clinical trial of Ribociclib (Kisqali(R)), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer (LEADER), the first circulating tumor DNA (ctDNA)-based study of a CDK4/6 inhibitor in ER-positive early stage breast cancer.
LEADER (part II) will randomize patients who have localized post-menopausal breast cancer with detectable ctDNA after surgery as evidence of minimal residual disease (MRD), and will determine tumor molecular response after Ribociclib in combination with endocrine therapy versus endocrine therapy alone. Natera's Signatera test will be used to determine patient enrollment eligibility based on presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint.
"With the overwhelming evidence that patients with detectable ctDNA are at high risk for relapse, our goal is to investigate a new treatment strategy for these patients and reduce risk of disease recurrence," said Aditya Bardia, MD, MPH, the study's principal investigator from MGCC, Harvard Medical School. "Since the LEADER trial is in the MRD setting, it is critical to use a highly sensitive assay."
Breast cancer remains the second leading cause of cancer death in women in the United States,1 and the U.S. Food and Drug Administration (FDA) has approved Ribociclib in combination with aromatase inhibitors as a first-line treatment option for advanced/metastatic (stage IV) disease.
"We are proud to partner with Massachusetts General Hospital on this exciting new approach of using Signatera personalized ctDNA analysis for enrollment and evaluation of treatment response to CDK4/6 inhibitors in the MRD setting," said Alexey Aleshin, MD, MBA, Natera's Senior Medical Director for Oncology. "We believe this collaboration may pave the way for more trials using ctDNA to study the effectiveness of an investigational drug in early stage breast cancer."
Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. 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's 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 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, Calif. It offers proprietary genetic testing services to oncologists, obstetricians, and transplant physicians, as well as to researchers and biopharmaceutical companies. 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 screening tests, or of the benefits of our screening 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350Media: Paul Greenland, VP of Corporate Marketing, firstname.lastname@example.org
1. How Common Is Breast Cancer? The American Cancer Society. Updated January 8, 2020. Accessed July 14, 2020. https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html.
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