Phase III EMERALD study of RAD 1901 meets primary endpoints in ER+/HER2- breast cancer.
There were two primary endpoints: progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring estrogen receptor 1 (ESR1) mutations. EMERALD met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup.
The safety profile of elacestrant exhibited in EMERALD was similar to that of the previous clinical trial. Overall, 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation. A full evaluation of the data is ongoing. Current plans are to have those results presented at the upcoming San Antonio Breast Cancer Symposium in December, 2021 and to publish them in a peer-reviewed journal.
ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/ HER2- mBC patients. Given these results, Menarini and Radius plan on proceeding with regulatory submissions in both the United States and European Union in 2022. In 2018, elacestrant received fast track designation from the FDA.
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