Radius Health and Menarini Group Report Positive Phase 3 Results from EMERALD Trial
Oct 20, 2021 By MarketDepth
Radius Health, Inc. (NASDAQ: RDUS) and The Menarini Group have reported positive topline results from EMERALD Trial Evaluating Elacestrant in Breast Cancer. EMERALD has met both primary endpoints of the trial. “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,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “The results pave the way towards our working with the regulators to bring elacestrant to patients with ER+/HER2- advanced or metastatic breast cancer, which remains a huge unmet medical need. Notably, the topline results were also positive for the ESR1 mutation sub segment, an important driver of resistance to endocrine therapy in ER+/HER2- mBC patients. We intend to share the data at the San Antonio Breast Cancer Symposium in December.”
“Advanced /metastatic ER+/HER2- BC pre-treated with endocrine therapy remains an area of high unmet medical need. Additional therapeutic options for this patient population are urgently needed. The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors. The results provide a significant advancement for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy.”
Dr. Aditya Bardia, MD, MPH of the MGH, Associate Professor at the Medicine Department at Harvard Medical School, and Principal Investigator for the EMERALD trial
Kelly Martin, Radius’ Chief Executive Officer, added, “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.” Martin continued, “The Menarini Group and its leadership team are terrific partners. All of us at Radius look forward to supporting them through U.S. NDA submission.”
