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In ESR1-mutated, ER+/HER2- mBC following progression on ET ORSERDU: 2x mPFS vs fulvestrant or AI1*

PRIMARY ENDPOINT IN EMERALD: mPFS IN PATIENTS WITH  ESR1-MUTATED mBC1

Primary endpoint in EMERALD: mPFS in patients with ESR1-Mutated mBC

  • Number of PFS events: 62 (54%) with ORSERDU vs 78 (69%) with fulvestrant or AI1

  • A statistically significant PFS was observed in the ITT population and in the subgroup of patients with ESR1-mutated mBC. The exploratory PFS analysis in the 250 patients (52%) without ESR1 mutations showed a HR of 0.86 (95% CI: 0.63-1.19); thus, improvement in the ITT population was primarily attributed to the results seen in the patients with ESR1-mutated mBC1

  • Prespecified, descriptive analyses: PFS rates at 3, 6, 12, and 18 months are based on Kaplan-Meier estimates and are not powered to detect statistical difference at these time points. 3 months: ORSERDU 55.9% (95% CI: 45.8-66.1) vs fulvestrant or AI 39.6% (95% CI: 29.4-49.7); 6 months: ORSERDU 40.8% (95% CI: 30.1-51.4) vs fulvestrant or AI 19.1% (95% CI: 10.5-27.8); 12 months: ORSERDU 26.8% (95% CI: 16.2-37.4) vs fulvestrant or AI 8.2% (95% CI: 1.3-15.1); 18 months: ORSERDU 24.3% (95% CI: 13.7-35.0) vs fulvestrant or AI (NE)3

*AI therapy included anastrozole, letrozole, or exemestane.1

Female ESR1-mutated mBC patient treated with ORSERDU®

More than 12,000 patients with ESR1-mutated mBC have been treated with ORSERDU3

Prescription pad

More than 5600 HCPs  have prescribed ORSERDU to date3

AI, aromatase inhibitor; CI, confidence interval; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; HCP, healthcare professional; HR, hazard ratio; ITT, intent to treat; mBC, metastatic breast cancer; mPFS, median progression-free survival; NE, not estimable; PFS, progression-free survival.

About endpoints
Exploratory post hoc analysis8.6 months mPFS in patients treated with prior ET + CDK4/6i  for 12 months or more7

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.

EXPLORATORY POST HOC ANALYSIS: mPFS IN PATIENTS WITH PRIOR ET + CDK4/6i FOR ≥12 MONTHS7

Exploratory post hoc analysis: mPFS in patients with prior ET + CDK4/6i FOR ≥12 months

~70% of patients in EMERALD had received prior ET + CDK4/6i therapy for ≥12 months8

Patients treated with prior ET + CDK4/6i for 6 months or more may still benefit from ORSERDU8†

AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; ET, endocrine therapy; HR, hazard ratio; mPFS, median progression-free survival; PFS, progression-free survival.

*AI therapy included anastrozole, letrozole, or exemestane.1 †4.14 months mPFS (95% CI: 2.20-7.79) for ORSERDU vs 1.87 (95% CI: 1.87-3.29) for fulvestrant or AI (HR=0.52 [95% CI: 0.36-0.74]).8

EMERALD trial: Post hoc exploratory subgroup analyses
Disclosure Statement

This links to a publication of the results of a company-sponsored study of ORSERDU® (elacestrant). The publication contains results from an exploratory, post hoc analysis of a company-sponsored study that are descriptive but not conclusive, are not controlled for type 1 error, and should be interpreted with caution.

It may include information that is not contained in the approved product labeling. Stemline Therapeutics, Inc. does not recommend the use of its product(s) inconsistent with the prescribing information.

Please see full Prescribing Information for ORSERDU.

Exploratory post hoc analysismPFS in clinically relevant patient types

Results of this exploratory post hoc analysis are descriptive but not conclusive of efficacy in particular subgroups, 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. ORSERDU is NOT indicated to target PIK3CA or TP53 mutations.

EXPLORATORY POST HOC ANALYSIS: mPFS In SUBGROUPS OF PATIENTS WITH  ESR1-MUTATED TUMORS AND PRIOR ET + CDK4/6i For ≥12 MONTHS7

mPFS, months

Patients with ESR1-mutated tumors

n (%)

ORSERDU (95% CI)

Fulvestrant or AI*
(95% CI)

HR (95% CI)

All patients with ESR1m

159 (100)

8.6 (4.14-10.84)

1.9 (1.87-3.68)

0.41 (0.26-0.63)

Bone metastases†

136 (86)

9.1 (5.49-16.89)

1.9 (1.87-3.71)

0.38 (0.23-0.62)

Liver and/or lung metastases‡

113 (71)

7.3 (2.20-10.84)

1.9 (1.84-1.94)

0.35 (0.21-0.59)

<3 metastatic sites§

82 (52)

9.0 (3.78-16.89)

1.9 (1.87-3.75)

0.41 (0.23-0.75)

≥3 metastatic sites§

53 (33)

10.8 (1.94-NE)

1.8 (1.77-2.10)

0.31 (0.12-0.79)

PIK3CA- and ESR1-mutated tumors||

62 (39)

5.5 (2.14-10.84)

1.9 (1.84-3.94)

0.42 (0.18-0.94)

TP53- and ESR1-mutated tumors

61 (38)

8.6 (3.65-24.25)

1.9 (1.84-3.52)

0.30 (0.13-0.64)

HER2-low expression

77 (48)

9.0 (5.49-16.89)

1.9 (1.84-3.75)

0.30 (0.14-0.60)

KEY SUBGROUP DATA7

Exploratory post hoc analysis: mPFS in subgroups of patients with ESR1-mutated tumors and prior ET + CDK4/6i for ≥12 months

AI, aromatase inhibitor; CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; CI, confidence interval; ESR1, estrogen receptor 1; ESR1m, estrogen receptor 1 mutation; ET, endocrine therapy; HER2, human epidermal growth factor receptor 2; HR, hazard ratio; IHC, immunohistochemistry; ISH, in situ hybridization; mPFS, median progression-free survival; NE, not estimable; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PIK3CAm, PIK3CA mutation; TP53, tumor protein 53; TP53m, TP53 mutation.

*AI therapy included anastrozole, letrozole, or exemestane.7 †85% of patients had bone and other sites of metastases (30% of these patients had no liver or lung involvement).7 ‡55% of patients had liver and other sites of metastases (10% of these patients had no lung or bone involvement); 25% of patients had lung and other sites of metastases (2% of these patients had no liver or bone involvement).7 §The number of metastatic sites was available for 135 of 159 patients with ESR1-mutated tumors and prior ET + CDK4/6i for ≥12 months.7 ||Includes E545K, H1047R, E542K, and others.7 Locally assessed HER2 IHC score of 1+ and 2+ with no ISH amplification. Data not available for all patients.7

Exploratory post hoc analysisORSERDU showed longer mPFS vs fulvestrant2,9

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.

PFS vs FULVESTRANT IN PATIENTS WITH ESR1-MUTATED mBC2,9

PFS in patients with detectable ESR1 mutation

73% of patients in the control arm of EMERALD were treated with fulvestrant (n=83)2

ESR1 mutations alter the binding pocket, leading to
constitutively active estrogen receptors10

Fulvestrant has decreased binding affinity for  ESR1-mutated receptors10

ORSERDU has strong binding affinity for ESR1-mutated receptors

Fulvestrant is not specifically indicated for ESR1-mutated, ER+/HER2- mBC11

ORSERDU has strong binding affinity for
ESR1-mutated receptors12,13

CI, confidence interval; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; mBC, metastatic breast cancer; mPFS, median progression-free survival; PFS, progression-free survival.

Exploratory post hoc analysisIn patients with ESR1m who did not receive prior chemotherapy, ORSERDU showed 5.3 months mPFS vs 1.9 months with fulvestrant or AI14*

Results of this exploratory post hoc analysis are descriptive but not conclusive of efficacy in this subgroup, 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.

EXPLORATORY POST HOC ANALYSIS:
mPFS IN PATIENTS WITHOUT PRIOR CHEMOTHERAPY14

Exploratory post hoc analysis: mPFS in patients with prior chemotherapy

AI, aromatase inhibitor; CI, confidence interval; ESR1m, estrogen receptor 1 mutation; HR, hazard ratio; mPFS, median progression-free survival; PFS, progression-free survival.

*AI therapy included anastrozole, letrozole, or exemestane.1

Learn more about Safety

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.

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 see full Prescribing Information.

References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-3256. 3. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 4. NCI Dictionary of Cancer Terms. PFS. Accessed March 17, 2025. https://www.cancer.gov/publications/dictionaries /cancer-terms/def/pfs 5. NCI Dictionary of Cancer Terms. Median survival. Accessed March 17, 2025. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/median-survival 6. Kok PS, Cho D, Yoon WH, et al. Validation of progression-free survival rate at 6 months and objective response for estimating overall survival in immune checkpoint inhibitor trials: a systematic review and meta-analysis. JAMA Netw Open. 2020;3(9):e2011809. 7. 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. 8. 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 [supplementary appendix]. 9. Bardia A, Neven P, Streich G, et al. Elacestrant, an oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC) following progression on prior endocrine and CDK4/6 inhibitor therapy: results of EMERALD phase 3 trial. Presented at: San Antonio Breast Cancer Symposium; December 7-10, 2021; San Antonio, TX. 10. Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021;23(1):85. 11. Faslodex [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 12. Bihani T, Patel HK, Arlt H, et al. Elacestrant (RAD1901), a selective estrogen receptor degrader (SERD), has antitumor activity in multiple ER+ breast cancer patient-derived xenograft models. Clin Cancer Res. 2017;23(16):4793-4804. 13. Bihani T, Patel HK, Arlt H, et al. Elacestrant (RAD1901), a selective estrogen receptor degrader (SERD), has antitumor activity in multiple ER+ breast cancer patient-derived xenograft models. Clin Cancer Res. 2017;23(16):4793-4804 [supplementary appendix]. 14. Kaklamani V, Bardia A, Aftimos P, et al. Subgroup analysis of patients with no prior chemotherapy in EMERALD: a phase 3 trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC). Presented at: American Society of Clinical Oncology; June 3-7, 2022; Chicago, IL.

This site is intended only for US healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

ORSERDU is a registered trademark of the Menarini Group.

© 2025 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 05/25 MAT-US-ELA-00796

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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.

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 see full Prescribing Information.

References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40(28):3246-3256. 3. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 4. NCI Dictionary of Cancer Terms. PFS. Accessed March 17, 2025. https://www.cancer.gov/publications/dictionaries /cancer-terms/def/pfs 5. NCI Dictionary of Cancer Terms. Median survival. Accessed March 17, 2025. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/median-survival 6. Kok PS, Cho D, Yoon WH, et al. Validation of progression-free survival rate at 6 months and objective response for estimating overall survival in immune checkpoint inhibitor trials: a systematic review and meta-analysis. JAMA Netw Open. 2020;3(9):e2011809. 7. 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. 8. 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 [supplementary appendix]. 9. Bardia A, Neven P, Streich G, et al. Elacestrant, an oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC) following progression on prior endocrine and CDK4/6 inhibitor therapy: results of EMERALD phase 3 trial. Presented at: San Antonio Breast Cancer Symposium; December 7-10, 2021; San Antonio, TX. 10. Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021;23(1):85. 11. Faslodex [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 12. Bihani T, Patel HK, Arlt H, et al. Elacestrant (RAD1901), a selective estrogen receptor degrader (SERD), has antitumor activity in multiple ER+ breast cancer patient-derived xenograft models. Clin Cancer Res. 2017;23(16):4793-4804. 13. Bihani T, Patel HK, Arlt H, et al. Elacestrant (RAD1901), a selective estrogen receptor degrader (SERD), has antitumor activity in multiple ER+ breast cancer patient-derived xenograft models. Clin Cancer Res. 2017;23(16):4793-4804 [supplementary appendix]. 14. Kaklamani V, Bardia A, Aftimos P, et al. Subgroup analysis of patients with no prior chemotherapy in EMERALD: a phase 3 trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC). Presented at: American Society of Clinical Oncology; June 3-7, 2022; Chicago, IL.