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Menarini Group and Radius Health, Inc. announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology
FLORENCE, Italy and BOSTON, May 19, 2022 (GLOBE NEWSWIRE) -- The Menarini Group (“Menarini”) and Radius Health, Inc. (“Radius”) (NASDAQ: RDUS) (collectively, the “Companies”) today announced that data from the pivotal phase 3 EMERALD clinical trial (NCT03778931) evaluating elacestrant as a monotherapy vs. standard of care (SOC; fulvestrant or aromatase inhibitor, AI) for the treatment of ER+/HER2- advanced or metastatic breast cancer were published in the Journal of Clinical Oncology1. Elacestrant is the first oral selective estrogen receptor degrader (SERD) demonstrating a significant improvement in PFS vs. SOC with manageable safety in a phase 3 trial for patients with ER-positive/HER2-negative advanced breast cancer. Dr. Aditya Bardia, breast medical oncologist and director of Breast Cancer Research at Mass General Cancer Center, Harvard Medical School and principal investigator of the EMERALD clinical trial, commented, “There is an urgent unmet need for oral SERDs that are safe and effective against ER-positive metastatic breast cancer after progression on earlier lines of therapy, including CDK4/6 inhibitors. EMERALD is the first study to demonstrate a significant improvement in clinical outcomes with elacestrant, an oral SERD monotherapy, versus standard of care in a randomized, global phase III study for patients with ER-positive/HER2-negative advanced breast cancer. Further research is needed to develop combination therapies as well as evaluate novel endocrine therapies for patients with early breast cancer.” As reported in the Journal of Clinical Oncology:
Patients were randomized 1:1 to elacestrant (400 mg orally daily) or SOC choice of fulvestrant or AI; the protocol recommended that patients previously treated with fulvestrant receive AI, and patients previously treated with AI receive fulvestrant. Among the 477 patients enrolled in the trial, 239 received elacestrant. Of the 165 patients who received fulvestrant, all were pretreated with AI during the treatment for metastatic disease except n=6 who received fulvestrant. Of the 73 who received AI, all were pretreated with fulvestrant except n=4. Primary endpoints were PFS by blinded independent central review (IRC) in all patients and patients with detectable ESR1 mutations. Elacestrant significantly reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation.
PFS rate at 12 months with elacestrant was 22.3% vs. 9.4% with SOC in the overall population, and 26.8% vs. 8.2% in the ESR1 mutation population. The most common treatment emergent adverse events (AEs) in patients receiving elacestrant were mild or moderate gastrointestinal events. Nausea was the most common AE.
A subgroup analysis of patients with no prior chemotherapy in EMERALD will be presented at ASCO 2022 (Abstract: 1100). Menarini plans to pursue combination studies and study the potential of elacestrant to be effective in addressing the highest unmet needs for ER+/HER2- patients. About Elacestrant (RAD1901) and EMERALD Phase 3 Study References
About Menarini About Radius Forward-Looking Statements These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor & Media Relations Contact: Menarini: Radius: |