Positive Phase III results for elacestrant in breast cancer
Family-owned Italian drugmaker Menarini Group and USA-based Radius Health (Nasdaq: RDUS) today announced positive top-line results from the EMERALD study.
The study was designed to evaluate elacestrant as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC). 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. Given these results, Menarini and Radius plan on proceeding with regulatory submissions in both the USA and European Union in 2022. In 2018, elacestrant received fast track designation from the US Food and Drug Administration.
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