Menarini Group And Radius Health Announce Positive EMERALD Trial Results

– Menarini Group and Radius Health Announce Positive First-Line Phase 3 Results of the EMERALD Trial Evaluating Elacestrant  in Breast Cancer

– The study met the two main endpoints in patients with advanced ER + / HER2- or Mbc

– The elacestrant becomes the first oral SERD with superior positive results in a pivotal study as monotherapy against SoC for the treatment of advanced ER + / HER2- or mBC

– elacestrant increased PFS in the general population and the ESR1 mutation subgroup

– Plans for regulatory filings in both the United States and Europe in 2022

– The data is planned to be presented at the San Antonio Breast Cancer Symposium in December 2021

The Menarini Group and Radius Health, Inc. positive results of the EMERALD study. The study was designed to evaluate elacestrant as monotherapy versus standard of care (SoC) for the treatment of advanced or metastatic ER + / HER2- breast cancer (mBC). There were two main endpoints: progression-free survival (PFS) in the general population and in patients with tumors harboring estrogen receptor 1 (ESR1) mutations.

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EMERALD met both primary endpoints, showing statistically significant PFS in the general population and in the ESR1 mutation subgroup. The safety profile of elacestrant exhibited at EMERALD was similar to that of the previous clinical trial. Given these results, Menarini and Radius plan to continue regulatory filings in both the United States and the European Union in 2022. In 2018, elacestrant received fast-track designation from the FDA.

“We are very excited that elacestrant is the first oral SERD to show positive first-line results in a pivotal trial as monotherapy versus SoC for the treatment of ER + HER2-advanced or mBC,” commented Elcin Barker Ergun , CEO of the Menarini Group. . “The results pave the way for our work with regulators to bring elacestrant to patients with advanced or metastatic ER + / HER2- breast cancer, which remains a large unmet medical need. In particular, the first-line results were also positive for the ESR1 mutation subsegment, an important driver of resistance to endocrine therapy in patients with ER + / HER2- mBC. in December”.

Elacestrant is a selective estrogen receptor degrader (SERD). It was being investigated in the phase 3 EMERALD trial as a possible 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 patients with ER + / HER2- mBC.

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“Advanced / metastatic ER + / HER2- BC pretreated with endocrine therapy remains an area of ​​great unmet medical need. Additional treatment options are urgently needed for this patient population,” said Aditya Bardia, MD, MGH MPH, MD, Associate Professor in the Department of Medicine, Harvard Medical School, and principal investigator of the EMERALD trial. “The trial results, which are statistically significant, demonstrate a clinically significant improvement in PFS in the elacestrant group versus standard of care endocrine in patients previously treated with endocrine therapies and CDK 4/6 inhibitors. The results provide a breakthrough significant for patients suffering from this devastating disease. It was also important to see the positive data for those patients with ESR1 mutations, which are known to confer additional resistance to standard endocrine therapy. ”

Kelly Martin , CEO of Radius, added that “completing the EMERALD test was a tremendous effort given the myriad of Covid-related hurdles around the world. Our collective teams did an outstanding job delivering the high test results. quality and ultimately successful, “said Martin. “The Menarini Group and their leadership team are fantastic partners. Everyone at Radius looks forward to supporting them through the US NDA presentation .”

A full evaluation of the data is underway. Current plans are to present those results at the next San Antonio Breast Cancer Symposium in December 2021 and publish them in a peer-reviewed journal.

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