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Selective Estrogen Receptor Degrader in Phase III Trial For Use in Resistant ER-Positive Breast Cancer
REDWOOD CITY, Calif., July 30, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH) today announced a strategic collaboration with Radius Health, Inc. (Radius, Nasdaq: RDUS) to pursue regulatory approval of the Guardant360® CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader (SERD) being studied in the treatment of advanced ER-positive, HER2-negative breast cancer resistant to CDK4/6 inhibitors in combination with hormone therapy.
The phase III clinical trial, EMERALD, is currently underway to assess the efficacy of elacestrant versus standard of care endocrine therapy in the overall population, as well as in patients who have been comprehensively genotyped using the Guardant360 test and harbor ESR1 mutations. Radius recently signed a global exclusive development and commercialization licensing agreement with Menarini Group for elacestrant. Radius will continue to conduct and complete the ongoing EMERALD trial through U.S. Food and Drug Administration (FDA) New Drug Application (NDA) filing.
“Given breast cancer’s inherent tumor heterogeneity and the high prevalence of bone metastasis in advanced disease, our Guardant360 liquid biopsy can help overcome the challenges of tissue and bone biopsies to reveal significantly more actionable mutations, including ESR1 mutations, which may play a role in resistance and which are being studied in Radius’ EMERALD trial,” said AmirAli Talasaz, Ph.D., Guardant Health President. “For patients with CDK4/6 resistant tumors, for whom few other treatment options exist, potential therapies such as elacestrant may represent a promising option.”
The Guardant360 blood test is increasingly being used to guide treatment in metastatic breast cancer, as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, the Guardant360 test analyzes 74 genes using cell-free tumor DNA from patient blood samples. The Guardant360 test is broadly covered by Medicare for use across the vast majority of advanced solid tumors and many private payers.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding any regulatory approval to be pursued by Guardant Health under its collaboration with Radius Health, Inc. and the potential benefits and advantages of the Guardant360 test, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.