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In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iEMERALD: The largest global, prospective, randomized, open-label, phase 3 trial in patients with ESR1 mutations1-3

ESR1-MUTATED mBC STUDY POPULATION (N=228)*

  • Postmenopausal women and men
  • ER+/HER2- advanced or metastatic breast cancer
  • Progression on 1-2 lines of ET, at least one in combination with a CDK4/6i
  • ≤1 line of chemotherapy for advanced or metastatic disease
  • ECOG PS 0 or 1
Stratification factors:presence of visceral metastases, previous fulvestrant use

Randomized 1:1

ORSERDU 345 mg (n=115)

Progressive disease or unacceptable toxicity

ENDOCRINE MONOTHERAPY OF
INVESTIGATOR'S CHOICE (n=113)

Fulvestrant, anastrozole, letrozole, or exemestane

Progressive disease or unacceptable toxicity

PRIMARY ENDPOINT

  • PFS in the ESR1-mutated mBC population†
    • Median PFS
Prespecified landmark PFS assessments:

3 months, 6 months, 12 months, 18 months

CDK4/6i, cyclin-dependent kinase 4/6 inhibitor; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer; PFS, progression-free survival.

*This global phase 3 trial included patients with and without identified ESR1 mutations (N=478). Results presented within are from the ESR1-mutated mBC population only.1,2

†PFS was assessed by an independent blinded imaging review committee.1

In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iBaseline characteristics were consistent with patients commonly seen in clinical practice

Every patient in EMERALD received a prior CDK4/6i1

Key demographics for the ORSERDU arm

  • Visceral metastases: ~70% of patients2

  • One prior line of ET in the advanced or metastatic setting: ~64% of patients2

  • Prior fulvestrant therapy: ~24% of patients2

  • Prior AI therapy: ~88% of patients2

BASELINE CHARACTERISTICS2

ORSERDUSOC endocrine monotherapy*
ParameterESR1-mutated mBC (n=115)ESR1-mutated mBC (n=113)

Median age, years (range)

64 (28-89)63 (32-83)

Race or ethnicity

White89.4%87.0%
Asian5.3%8.7%
Hispanic8.7%8.8%
Black or African American4.3%4.3%
Other/unknown1.1%0%

ECOG PS

058.3%54.9%
141.7%45.1%

Visceral metastases†

70.4%74.3%

Prior adjuvant therapy

53.9%57.5%

Prior CDK4/6i

100%100%

Prior lines of ET in advanced or metastatic setting

163.5%61.1%
236.5%38.9%

Prior lines of chemotherapy in advanced or metastatic setting

077.4%71.7%
122.6%28.3%

Any prior ET

97.4%96.5%
Fulvestrant23.5%24.8%
Al87.8%85.0%

AI, aromatase inhibitor; SOC, standard of care.

*SOC endocrine monotherapy included either fulvestrant, anastrozole, letrozole, or exemestane.1

†Includes lung, liver, brain, pleural, and peritoneal involvement.2

NOW APPROVED:  The first and only therapy indicated for ESR1-mutated mBC1
In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iDoubled mPFS vs SOC endocrine monotherapy1*

PRIMARY ENDPOINT IN EMERALD: PFS IN PATIENTS WITH ESR1-MUTATED mBC

PFS in Patients Taking ORSERDU™ (elacestrant) vs SOC Endocrine Monotherapy

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

CI, confidence interval; HR, hazard ratio; ITT, intent to treat; mPFS, median progression-free survival.

*mPFS was the primary endpoint. SOC endocrine monotherapy included either fulvestrant, anastrozole, letrozole, or exemestane.

†95% CI: 2.2-7.3.

‡95% CI: 1.9-2.1.

About endpoints

Selected 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.

Please see additional Important Safety Information below. Please see full Prescribing Information.

In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iIn a post hoc analysis, mPFS results vs fulvestrant were consistent with the primary endpoint results7

PFS vs FULVESTRANT IN PATIENTS WITH ESR1-MUTATED mBC

PFS in Patients Taking ORSERDU™ (elacestrant) vs Fulvestrant

  • Results are observational in nature. There was no prespecified statistical procedure controlling for type 1 error

*95% CI: 2.2-7.3.

†95% CI: 1.8-2.1.

In ER+/HER2- mBC with identified ESR1 mutations following initial ET ± a CDK4/6iPost hoc analysis: mPFS by duration of prior CDK4/6i therapy8*

mPFS IN PATIENTS WITH ESR1-MUTATED mBC TREATED WITH PRIOR CDK4/6i FOR ≥12 MONTHS

mPFS in Patients Taking ORSERDU™ (elacestrant) vs SOC Endocrine Monotherapy

mPFS IN PATIENTS BASED ON DURATION OF PRIOR CDK4/6i8

Duration of prior CDK4/6i therapyORSERDUSOC endocrine monotherapy†
(n=103)(n=102)
≥6 months
HR=0.52 (95% CI: 0.36-0.74)		4.14
(2.20-7.79)		1.87
(1.87-3.29)
(n=78)(n=81)
≥12 months
HR=0.41 (95% CI: 0.26-0.63)		8.61
(4.14-10.84)		1.91
(1.87-3.68)
(n=55)(n=56)
≥18 months
HR=0.47 (95% CI: 0.27-0.80)		8.61
(5.45-16.89)		2.10
(1.87-3.75)

  • The HR of 0.41 in patients with prior CDK4/6i exposure for ≥12 months equates to a 59% reduction in risk of progression or death (95% CI: 0.26-0.63)8

  • Results are observational in nature. There was no prespecified statistical procedure controlling for type 1 error

*Post hoc analysis of mPFS results in the EMERALD trial based on duration of prior CDK4/6i usage.

†SOC endocrine monotherapy included either fulvestrant, anastrozole, letrozole, or exemestane.1

‡95% CI: 4.1-10.8.8

§95% CI: 1.9-3.7.8

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.

INDICATION

ORSERDU (elacestrant) 345 mg tablets are 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, including Patient 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 January 14, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pfs. 5. NCI Dictionary of Cancer Terms. Median survival. Accessed January 14, 2023. 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, 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. 8. Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Presented at: San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.

ORSERDU is a trademark of the Menarini Group.

© 2023 Stemline Therapeutics, Inc., a Menarini Group Company. All rights reserved. 05/23 ELA-05033v3

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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.

INDICATION

ORSERDU (elacestrant) 345 mg tablets are 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, including Patient 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 January 14, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/pfs. 5. NCI Dictionary of Cancer Terms. Median survival. Accessed January 14, 2023. 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, 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. 8. Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Presented at: San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, TX.