Commercial-stage biopharmaceutical company Radius Health Inc. (RDUS:NASDAQ) and global pharmaceutical and diagnostics firm Menarini Group, today announced positive topline results from the Phase 3 EMERALD study of selective estrogen receptor degrader (SERD), elacestrant, which is being evaluated as a second- or third-line monotherapy in treatment of ER+/HER2- advanced/metastatic breast cancer patients.
The companies stated that the EMERALD trial was structured to study the effects of elacestrant as a monotherapy versus the currently accepted standard of care (SoC) for treating ER+/HER2- advanced or metastatic breast cancer (mBC). The firms indicated that the two pre-established primary endpoints in the study were identified as "progression-free survival (PFS) in the overall population and PFS in patients with tumors harboring estrogen receptor 1 (ESR1) mutations." Several additional secondary endpoints were also measured including overall survival (OS),
objective response rate (ORR) and duration of response (DOR).
The two companies reported that elacestrant successfully met both primary endpoints in the study and demonstrated "statistically significant PFS in the overall population and ESR1 mutation subgroup."
The firms advised that based upon the positive results observed in the study, they intend to proceed with regulatory submissions in 2022 in the U.S. and the EU. The report mentioned that in 2018, the U.S. Food and Drug Administration (FDA) approved fast track status for elacestrant.
"Completing the EMERALD trial was a tremendous effort." — Kelly Martin,
Radius Health CEO
Elcin Barker Ergun, CEO of the Menarini Group, remarked, "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…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," Ergun added.
Dr. Aditya Bardia, M.D., MPH of the MGH, Associate Professor at the Medicine Department at Harvard Medical School, and Principal Investigator for the EMERALD trial, stated, "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…It was also important to see the positive data for those patients with ESR1 mutations, known to confer additional resistance to standard endocrine therapy."
Radius Health's CEO Kelly Martin commented, "Completing the EMERALD trial was a tremendous effort given the myriad of Covid related obstacles across the globe…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."
The company stated that a complete review of the data from the EMERALD study is now being performed and that it plans to present the results to the San Antonio Breast Cancer Symposium in December of this year.
Radius explained that elacestrant (RAD1901) is a selective estrogen receptor degrader (SERD) that has been outlicensed to the Menarini Group. Once daily oral elacestrant is currently being investigated for use as a single agent or combination therapy in patients with ER+/ HER2- advanced breast cancer.
The EMERALD Phase 3 clinical trial is a randomized study of 466 patients who had previously received either one or two lines of endocrine treatment including a cyclin-dependent kinase (CDK) 4/6 inhibitor. Participants in the study were administered elacestrant or an approved hormonal agent selected by the investigator.
The Menarini Group is a large international pharmaceutical and diagnostics firm headquartered in Florence, Italy that operates 18 production sites and 10 research and development centers. The company's activities are centered around developing and commercializing therapeutics to address unmet medical needs in the areas of analgesia, cardiology, diabetes, gastroenterology, infectious diseases, inflammation, oncology and pneumology. The company employs more than 170,000 people, has an annual turnover of US$4.2 billion and markets its products in 140 countries.
Radius is a global biopharmaceutical company based in Boston, Mass. that is focused on the areas of bone health, oncology and orphan diseases. The firm indicated that "its lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture." The company is also currently evaluating abaloparatide injection for potential applications in treating osteoporosis in men and as a transdermal delivery system for possible use in treatment of postmenopausal women with osteoporosis.
Radius Health began the day with a market cap of around $730.7 million with approximately 969.5 million shares outstanding and a short interest of about 9.6%. RDUS shares opened 36% higher today at $21.10 (+$5.64, +36.48%) over yesterday's $15.46 closing price. The stock has traded today between $17.69 and $23.00 per share and is currently trading at $18.12 (+$2.66, +17.21%).
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