The Menarini Group and Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group, announced that they will present new data related to elacestrant in upcoming congresses. Elacestrant has been approved by the FDA for treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. New data will be presented at the upcoming 2023 European Society for Medical Oncology (ESMO) Breast Cancer Congress and the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

About the EMERALD Phase 3 Study (NCT03778931): The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator's choice of an approved hormonal agent.

The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. About ORSERDU® (elacestrant) Indication: ORSERDU (elacestrant), 345 mg tablets, is approved by the U.S. Food & Drug Administration (FDA) for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).

Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.