Natera Announces Prospective Randomized Clinical Trial to Evaluate Palbociclib in Early Stage Breast Cancer Patients Who Test Positive with Signatera™
SAN CARLOS, Calif., Oct. 2, 2020 /PRNewswire/ --Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA, today announced that its Signatera molecular residual disease (MRD) test will be used in the DARE study, a multi-center clinical trial of palbociclib (IBRANCE®), a CDK4/6 inhibitor developed by Pfizer for the treatment of HR-positive, HER2-negative advanced breast cancer when given in combination with an aromatase inhibitor or fulvestrant.
The DARE study is a randomized, Phase II trial of ctDNA-guided second line adjuvant therapy for stage II-III, HR-positive, HER2-negative breast cancer. DARE will be conducted in the United States through Criterium, Inc. d/b/a the Academic Breast Cancer Consortium (ABRCC) network, which plans to identify about 100 MRD-positive patients for enrollment in the study. These 100 patients will be randomized to continue their current adjuvant endocrine therapy or start treatment with palbociclib plus fulvestrant for two years. Signatera is to be used for patient enrollment eligibility and continued therapy effectiveness monitoring after randomization.
"Detecting relapse before it becomes clinically symptomatic requires a test with high sensitivity and specificity," said Lajos Pusztai, MD, DPhil, Professor of Medicine (Medical Oncology); Co-Leader, Genetics, Genomics and Epigenetics Research Program, Yale Cancer Center, Yale School of Medicine and Principal Investigator of the trial. "Signatera enables us to confidently identify patients with molecular relapse when the disease burden is so low that it is undetectable with imaging. The trial will test if early intervention at this stage could delay or avert a clinical relapse."
Palbociclib was the first CDK4/6 inhibitor to be approved by the FDA as a therapy for patients with HR-positive, HER2-negative advanced breast cancer when taken in combination with endocrine therapy; however, efficacy has not yet been demonstrated in early stage disease. Each year, approximately 69,000 women are diagnosed with Stage II or III HR-positive breast cancer in the United States.1,2
"We are delighted to collaborate with Yale and Criterium/ABRCC to investigate the efficacy of palbociclib in patients with detectable residual disease based on Signatera," said Alexey Aleshin, MD, MBA, Natera's Senior Medical Director for Oncology. "This is the second clinical trial using Signatera to evaluate the efficacy of a CDK4/6 inhibitor, and it heralds the significant utility of personalized MRD testing for early relapse detection in patients with 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 and 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.
About Criterium and ABRCC
Founded in 1991, Criterium, Inc. is a full-service, global CRO offering a unique mix of high-quality clinical research services and communication processes for the biopharmaceutical, pharmaceutical, and medical device industries to manage trials from initial planning to approval. The Oncology Consortia of Criterium (founded in 2008) are a collaboration of outstanding Cancer Research Consortia that deliver innovative research and unparalleled expertise.
The Academic Breast Cancer Consortium (ABRCC) is represented by Key Opinion Leaders (KOLs) and top Investigators at 14 of the most prestigious institutions in the USA. ABRCC employs a full service research model created and designed to enhance the state of care for breast cancer patients, with a goal of expediting the process of identifying and efficiently testing active new compounds for the treatment of these and related cancers. Visit the website: www.criteriuminc.com and visit ABRCC on the web.
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.
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Company Codes: NASDAQ-NMS:NTRA