Email Template
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Dear Healthcare Professional, |
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We are excited to share two recent RWE analyses, evaluating more than a total of 1,000
patients with ESR1-mutated, ER+/HER2- aBC, the findings of which supplement ORSERDU’s
data in the EMERALD post hoc subgroup analysis.1,2 |
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In the EMERALD Phase 3 study, ORSERDU demonstrated a 45% reduction in the risk of progression or death vs.
fulvestrant or AI* in ESR1-mutated, ER+/HER2- mBC patients following progression on ET +
CDK4/6i3 |
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Primary endpoint in EMERALD |
3.8 months (95% CI: 2.2-7.3) for ORSERDU
(n=115) vs. 1.9 months (95% CI:
1.9-2.1)
for fulvestrant or AI* (n=113).
HR=0.55
(95% CI: 0.39-0.77); P=0.00053 |
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Exploratory post hoc analysis†: Patients with prior ET +
CDK4/6i for ≥12 months |
8.6 months (95% CI: 4.1-10.8) for ORSERDU
(n=78) vs. 1.9 months (95% CI: 1.9-3.7)
for fulvestrant or AI* (n=81).
HR=0.41 (95% CI:
0.26-0.63)4 |
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Primary endpoint in EMERALD |
3.8 months (95% CI: 2.2-7.3) for ORSERDU
(n=115) vs. 1.9 months (95% CI: 1.9-2.1)
for fulvestrant or AI* (n=113).
HR=0.55 (95% CI:
0.39-0.77); P=0.00053 |
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Exploratory post hoc analysis†: Patients with prior ET +
CDK4/6i for ≥12 months |
8.6 months (95% CI: 4.1-10.8) for ORSERDU
(n=78) vs. 1.9 months (95% CI: 1.9-3.7)
for fulvestrant or AI* (n=81).
HR=0.41 (95% CI:
0.26-0.63)4 |
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*AI therapy included anastrozole, letrozole, or exemestane.3
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†Results of this exploratory post hoc analysis are descriptive but not conclusive of
efficacy, are not controlled
for type 1 error, and require cautious interpretation. Small patient numbers can be a limitation of
subgroup
analyses and could represent chance findings.
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RWE Supplements ORSERDU’s Data
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Observational retrospective analyses are not intended for direct comparisons with clinical trials.
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SELECT IMPORTANT SAFETY INFORMATION |
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The labeling for ORSERDU contains warnings and precautions for
dyslipidemia and embryo-fetal toxicity. |
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The most common serious adverse reactions in ≥1% of patients who
received ORSERDU were musculoskeletal pain and nausea. |
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The most common adverse reactions, including laboratory abnormalities,
in ≥10% of patients who received ORSERDU were musculoskeletal pain, nausea,
increased cholesterol, increased AST, increased triglycerides, fatigue, decreased
hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine,
decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and
dyspepsia. |
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Please see additional Important Safety Information below. |
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STUDY DESIGN: EMERALD was an open-label, global, phase 3 trial of postmenopausal
women or men with confirmed ER+/HER2- advanced or metastatic breast cancer (N=478) who
had progressed after 1-2 lines of ET, at least one in combination with a CDK4/6i,
randomized (1:1) to receive ORSERDU or endocrine therapy (fulvestrant) or an aromatase
inhibitor (anastrozole, letrozole, or exemestane). A major efficacy endpoint was PFS by BIRC in
patients with ESR1m (n=228). An exploratory post hoc analysis evaluated
efficacy and safety in patients with ESR1m treated with prior ET + CDK4/6i for ≥12 months
(n=159).3,4 |
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Click here to request more information
from a sales representative. | | | | 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. |
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| • | | 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. |
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| 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). |
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| • | | 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%). |
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| 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. |
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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. | | | | 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. | | |
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 click here to see the full
Prescribing Information. | | | | For State pricing disclosures for ORSERDU®, please click
HERE. | | |
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| | | Abbreviations:
aBC, advanced breast cancer; AI, aromatase inhibitor; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BIRC, blinded imaging review committee; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ESR1m, estrogen receptor 1 mutation; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; mBC, metastatic breast cancer; mPFS, median progression-free survival; PFS, progression-free survival; RWE, real-world evidence. | | |
| References: 1. Lloyd MR, Ali A, Weipert CM, et al. Impact of prior treatment, ESR1mutational landscape, and co-occurring PI3K pathway status on real-world elacestrant outcomes in patients with hormone receptor-positive/HER2- negative advanced breast cancer. Poster presented at San Antonio Breast Cancer Symposium (SABCS), 10–14 December 2024, San Antonio, TX, USA. PS7-05. 2.
Swallow E, Maitland J, Sarathy K, et al. Elacestrant real-world progression-free survival (rwPFS) of adult patients with ER+/HER2-, advanced breast cancer: a retrospective analysis using insurance claims in the United States. Oral presentation at San Antonio Breast Cancer Symposium (SABCS), 10–14 December 2024, San Antonio, TX, USA. P3-10-08. 3. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 4. Bardia A, Cortés J, Bidard FC, et al. Elacestrant in ER+, HER2- metastatic breast cancer with ESR1-mutated tumors: subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res
. 2024;30(19):4299-4309. | | |
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 | | | | ORSERDU is a registered trademark of the Menarini Group. |
| | | © 2025 Stemline Therapeutics, Inc., a Menarini Group Company. | | 750 Lexington Avenue, 4th Floor,
New York, NY 10022. | | All rights reserved. 10/25 MAT-US-ELA-01091 |
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