Benzinga | Oct 20, 2021 08:33AM EDT

Radius Health, Menarini Group Report Phase 3 Topline Results From EMERALD Trial For Elacestrant In Breast Cancer: 'Study met both primary endpoints in patients with ER+/HER2- advanced or mBC'

* Study met both primary endpoints in patients with ER+/HER2- advanced or mBC

* Elacestrant becomes the first oral SERD with positive topline results in pivotal study as a monotherapy versus SoC for the treatment of ER+/HER2- advanced or mBC

* Elacestrant extended PFS in the overall population and the ESR1 mutation subgroup

* Plans for regulatory submissions in both the United States and Europe in 2022

* Data planned to be presented at the San Antonio Breast Cancer Symposium in December, 2021

FLORENCE, Italy and BOSTON, Oct. 20, 2021 (GLOBE NEWSWIRE) -- the Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ:RDUS) (collectively, the "Companies") today announced positive topline 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 United States and European Union in 2022. In 2018, elacestrant received fast track designation from the FDA.

"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."

Elacestrant is a selective estrogen receptor degrader (SERD). It was being investigated in the Phase 3 EMERALD trial as a potential once daily, oral treatment, in patients with ER+/ HER2- mBC. Overall, 466 patients were enrolled in the study, including 220 (47%) with tumors harboring an Estrogen Receptor 1 (ESR1) mutation. ESR1 mutations are important drivers for the development of resistance to endocrine therapy in ER+/ HER2- mBC patients.

"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," said 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. "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."

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."

A full evaluation of the data is ongoing. Current plans are to have those results presented at the upcoming San Antonio Breast Cancer Symposium in December, 2021 and to publish them in a peer-reviewed journal.