Radius Health Reports Positive Phase 3 Cancer Treatment Trial Results

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Investing.com — Radius Health (NASDAQ:RDUS) and the Menarini Group announced positive topline results from their study of a treatment for advanced or metastatic breast cancer.

Radius shares rose 21% on Wednesday. 

The study was designed to assess the treatment, elacestrant, as a monotherapy versus the standard of care for the disease. 

There were two primary endpoints for the study, which were both met— progression-free survival in the overall population and progression-free survival in patients with tumors harboring estrogen receptor 1 mutations.

“We are extremely excited as elacestrant is the first oral SERD to show positive topline results in a pivotal trial as a monotherapy vs SoC for the treatment of ER+HER2-advanced or mBC,” said Elcin Barker Ergun, CEO of the Menarini Group.

Elacestrant received fast track designation from the Food and Drug Administration in 2018, and the companies said they will now progress with regulatory submissions in both the U.S. and EU in 2022. 

There were 466 patients in the study, including 220 with tumors harboring an Estrogen Receptor 1 mutation. 

Radius’ CEO, Kelly Martin, commented: “Completing the EMERALD trial was a tremendous effort given the myriad of Covid related obstacles across the globe. Our collective teams did an outstanding job delivering the results of the trial in a high-quality and, ultimately, successful manner.”