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    Home > Biochemistry News > Biotechnology News > Menarini and Radius Announce Positive Topline Results for Phase 3

    Menarini and Radius Announce Positive Topline Results for Phase 3

    • Last Update: 2021-12-04
    • Source: Internet
    • Author: User
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    -The study meets the two primary endpoints of ER+/HER2-advanced or metastatic breast cancer (mBC) patients

    -Elacestrant is the first oral SERD to show positive top-line results in key clinical trials as a monotherapy in ER+HER2 advanced or mBC treatment compared with SoC

    -Elacestrant prolongs the PFS of the total patient group and ESR1 mutation subgroup

    -Plans to submit regulatory documents in the U.


    -Plans to publish data at the San Antonio Breast Cancer Symposium in December 2021

    Florence, Italy and Boston, October 22, 2021/PRNewswire/ - Menarini Group ("Menarini") and Radius Health, Inc.


    This study aims to evaluate the efficacy and safety of Elacestrant as a single-agent therapy compared with standard care (SoC) in the treatment of patients with ER+/HER2- advanced or metastatic breast cancer


    The EMERALD study reached two common primary endpoints: both the overall population and the ESR1 mutation subgroup had a statistically significant improvement in PFS


    Menarini Group CEO Elcin Barker Ergun said: "We are very excited, because Elacestrant is the first in the treatment of ER+HER2 advanced or mBC, as a monotherapy, compared with SoC in key clinical trials.


    Elacestrant is a selective estrogen receptor degrading agent (SERD)


    Dr.


    Radius Chief Executive Kelly Martin added: “Given the large number of COVID-19-related obstacles around the world, it takes a lot of effort to complete the EMERALD trial


    The data is currently being fully evaluated


    About the Phase 3 study of Elacestrant (RAD1901) and EMERALD 

    Elacestrant is a selective estrogen receptor degrading agent (SERD), which has been outsourced to Menarini Group and is currently being evaluated as a once-daily oral treatment for patients with ER+/HER2- advanced breast cancer


    About Menarini 

    Menarini Group is a leading international pharmaceutical and diagnostic company with more than 17,000 employees and a turnover of 4.


    About Radius 

    Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the fields of bone health, orphan diseases and oncology


    Forward-looking statement 

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995


    These forward-looking statements are based on management's current expectations


    Source: Menarini IFR

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