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EMERALD Trial: An Analysis of Key Biomarkers and Patient Subgroups

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Learn about the EMERALD trial including a post-hoc subgroup analysis of patients with ER-positive/HER2-negative ESR1-mutated metastatic breast cancer following progression on ET.

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  • Overview

    The results from the phase III EMERALD trial led to the approval of  ORSERDU® (elacestrant) as the first oral selective estrogen receptor degrader for ER-positive/HER2-negative metastatic breast cancer patients with ESR1 mutations after disease progression following at least one line of endocrine therapy.1 But given the results from prior analyses, clinicians wanted to better understand the data for elacestrant in subgroups of patients with key clinical or biomarker characteristics, and so a post hoc analysis of elacestrant in these subgroups who typically have a poorer prognosis was conducted. Explore the EMERALD trial and the key outcomes from this subgroup analysis with Dr. Jennifer Caudle and medical oncologist Dr. Joyce O'Shaughnessy.

  • INDICATION

    ORSERDU (elacestrant) is indicated 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.

  • IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    • Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid profile prior to starting and periodically while taking ORSERDU.
    • Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose.

    Adverse Reactions

    • Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each).
    • The most common adverse reactions (≥10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%).

    Drug Interactions

    • Concomitant use with CYP3A4 inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU.

    Use in Specific Populations

    • Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose.
    • Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B).

    The safety and effectiveness of ORSERDU in pediatric patients have not been established.

    ORSERDU is available as 345 mg tablets and 86 mg tablets.

    To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please see full Prescribing Information, including Patient Information.

    Reference:

    1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company; 2023.

     

    MAT-US-ELA-00160 / Copyright 2024 - Stemline Therapeutics, Inc.
    All rights reserved. 04/2024

Schedule20 Jul 2024