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ESR1 Mutations
ESR1m emergenceTesting
Safety
background
In ER+/HER2- ESR1-mutated mBC following progression on ETORSERDU demonstrated a manageable safety profile1Majority of ARs were Grade 1 or 21

ARs (≥10%) IN PATIENTS IN EMERALD1*

ORSERDU (n=237)

SOC endocrine monotherapy (n=230)

ARs

All grades (%)

Grade 3/4 (%)

All grades (%)

Grade 3/4 (%)

Musculoskeletal and connective tissue disorders

Musculoskeletal pain§

41

7

39

1

Gastrointestinal disorders

Nausea

35

2.5

19

0.9

Vomiting§

19

0.8

9

0

Diarrhea

13

0

10

1

Constipation

12

0

6

0

Abdominal pain§

11

1

10

0.9

Dyspepsia

10

0

2.6

0

General disorders

Fatigue§

26

2

27

1

Metabolism and nutrition disorders

Decreased appetite

15

0.8

10

0.4

Nervous system

Headache

12

2

12

0

Vascular disorders

Hot flush

11

0

8

0

  • Serious ARs occurred in 12% of patients who received ORSERDU1

    • Serious ARs in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%)1
  • No Grade 3 or 4 diarrhea with ORSERDU

  • Nausea was a common AR1:

    • The majority had Grade 1 or 2; no Grade 41
    • Low discontinuation rate due to nausea: 1.3%1
    • Low reactive antiemetic use across arms2:
      • 8% with ORSERDU

      • 4% with fulvestrant

      • 10% with AIs

94%

of patients taking ORSERDU did not discontinue treatment due to ARs1II

Low discontinuation rate due to ARs: 6%1

Low dose reductions due to ARs: 3%1

Low dose interruptions due to ARs: 15%1

  • Fatal ARs occurred in 1.7% of patients who received ORSERDU vs 2.6% of patients who received SOC

  • No patients in either treatment arm had sinus bradycardia2

AI, aromatase inhibitor; ARs, adverse reactions; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; SOC, standard of care.

*ARs were evaluated in patients with or without ESR1-mutated mBC (N=467) and were graded using NCI CTCAE version 5.0.1

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

Only includes Grade 3 ARs.1

§Includes other related terms.1

||ARs that resulted in permanent discontinuation of ORSERDU in >1% of patients were musculoskeletal pain (1.7%) and nausea (1.3%).1

Fatal ARs included cardiac arrest, septic shock, diverticulitis, and unknown cause (1 patient each).1


In ER+/HER2- ESR1-mutated mBC following progression on ETORSERDU demonstrated a manageable safety profile1

SELECT LABORATORY ABNORMALITIES (≥10%)*

ORSERDU

SOC endocrine monotherapy

All grades (%)

Grade 3/4 (%)

All grades (%)

Grade 3/4 (%)

Chemistry

Cholesterol increased

30

1

17

0

AST increased

29

0

34

1

Triglycerides increased

27

2

15

1

ALT increased

17

0

24

1

Sodium decreased

16

1

15

0

Creatinine increased

16

0

6

0

Hematology

Hemoglobin decreased

26

1

20

2

Monitor lipid profile prior to starting and periodically while taking ORSERDU1

alt="Monitoring Blood Glucose

No concomitant or prophylactic medications required in PI

alt="Monitoring Blood Glucose

No monitoring blood glucose levels prior to or during treatment required in PI

alt="Monitoring Blood Glucose

No ECGs or monitoring QTcF intervals required in PI

alt="Monitoring Blood Glucose

No baseline or periodic eye exams required in PI

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECG, electrocardiogram; ER+, estrogen receptor-positive; ESR1, estrogen receptor 1; ET, endocrine therapy; HER2-, human epidermal growth factor receptor 2-negative; mBC, metastatic breast cancer; PI, prescribing information; QTcF, QT interval corrected by Fridericia’s formula; SOC, standard of care.

*The denominator used to calculate the rate varied from 29 to 236 for ORSERDU and from 37 to 225 for SOC endocrine monotherapy based on the number of patients with a baseline value and at least 1 post-treatment value.1

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

Learn more about Dosing

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, including Patient Information.

References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 3. 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.

ORSERDU is a registered trademark of the Menarini Group.

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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, including Patient Information.

References: 1. ORSERDU [prescribing information]. New York, NY: Stemline Therapeutics, Inc., a Menarini Group Company, 2023. 2. Data on file. Stemline Therapeutics, Inc., a Menarini Group Company. 3. 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.