- The Menarini Group and Radius Health Inc RDUS have announced topline results from the EMERALD Phase 3 study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients.
- 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.
- The safety profile of elacestrant exhibited in EMERALD was similar to that of the previous clinical trial.
- Menarini and Radius plan on proceeding with regulatory submissions in both the U.S. and European Union in 2022.
- Elacestrant is a selective estrogen receptor degrader (SERD). Overall, 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation.
- A complete evaluation of the data is ongoing. Current plans are to present those results at the upcoming San Antonio Breast Cancer Symposium in December 2021 and publish them in a peer-reviewed journal.
- Price Action: RDUS shares are up 33% at $20.57 during the premarket session on the last check Wednesday.
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