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Italy's Menarini, Radius Health Report Positive Data From Elacestrant Phase 3 EMERALD Clinical Trial

Italian pharmaceutical company Menarini Group and Radius Health, Inc. (RDUS) announced Friday positive data from the pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as a monotherapy vs. standard of care for the treatment of ER+/HER2- advanced or metastatic breast cancer.

The companies noted that Emerald study met both its primary end points of Progression-free survival or PFS in overall population and in ESR1 mutated patients.

Elacestrant is the first oral selective estrogen receptor degrader or SERD demonstrating a significant improvement in PFS vs. SOC with manageable safety in a phase 3 trial for patients with ER-positive/HER2-negative advanced breast cancer.

The data were published in the Journal of Clinical Oncology.

In the trial, the most common treatment emergent adverse events or AEs in patients receiving elacestrant were mild or moderate gastrointestinal events.

Menarini plans to pursue combination studies and study the potential of elacestrant to be effective in addressing the highest unmet needs for ER+/HER2-patients.

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