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In ER+, HER2– MBC

Resistance to an AI often develops due to acquired ESR1 mutations2

Up to 50%

of patients will develop ESR1-mutated MBC during treatment with an AI2

Identifying patients with ESR1-mutated MBC3:

  • Her disease has stopped responding to an AI +/− CDK4/6i
  • A liquid biopsy is immediately ordered
  • ESR1 mutation is detected
  • Extend her oral ET with Inluriyo1,4
Woman looking inquisitively into the camera.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide recommendations for patients with ER+, HER2– recurrent MBC5

ESR1 Testing Recommendation5,6: National Comprehensive Cancer Network® (NCCN®) recommends testing for ESR1-mutations by using NGS or PCR (ctDNA preferred) to inform treatment decision-making. Assess for ESR1 mutations at progression following prior lines of ET.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

When resistance to an AI disrupts her treatment,
test for ESR1 mutations.3

AI=aromatase inhibitor; CDK4/6i=cyclin-dependent kinase 4 and 6 dual inhibitor; ctDNA=circulating tumor DNA; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; ET=endocrine therapy; HER2–=human epidermal growth factor receptor 2-negative; MBC=metastatic breast cancer; NCCN=National Comprehensive Cancer Network; NGS=next-generation sequencing; PCR=polymerase chain reaction

References:

  1. Inluriyo. Prescribing Information. Lilly USA, LLC.
  2. Venetis K, Pepe F, Pescia C, et al. ESR1 mutations in HR+/HER2–metastatic breast cancer: enhancing the accuracy of ctDNA testing. Cancer Treat Rev. 2023;121:102642. doi:10.1016/j.ctrv.2023.102642
  3. Betz M, Massard V, Gilson P, et al. ESR1 gene mutations and liquid biopsy in ER-positive breast cancers: a small step forward, a giant leap for personalization of endocrine therapy? Cancers. 2023;15(21):5169. doi:10.3390/cancers15215169
  4. Burstein HJ, DeMichele A, Somerfield MR, Henry NL; Biomarker Testing and Endocrine and Targeted Therapy in Metastatic Breast Cancer Expert Panels. Testing for ESR1-mutations to guide therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline rapid recommendation update. J Clin Oncol. 2023;41(18):3423-3425. doi:10.1200/JCO.23.00638
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V2.2026. ©National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed March 1, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.
  6. Gradishar WJ. Highlights of the NCCN 2024 Annual Conference: updates to the management of HR-positive, HER2– negative breast cancer. J Natl Compr Canc Netw. 2024;22(Suppl):e245010. doi:10.6004/jnccn.2024.5010

INDICATION

Inluriyo™ is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.1

IMPORTANT SAFETY INFORMATION FOR INLURIYO™ (imlunestrant)

Warnings and Precautions - Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, Inluriyo can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of imlunestrant to pregnant rats during the period of organogenesis led to embryo-fetal mortality and structural abnormalities at maternal exposures that were below the human exposure at the recommended dose based on area under the curve (AUC). Avoid the use of imlunestrant in pregnant women. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Inluriyo and for 1 week after the last dose.

Serious and Fatal Adverse Reactions

Serious adverse reactions occurred in 10% of patients who received Inluriyo. Serious adverse reactions in >1% of patients included pleural effusion (1.2%). Fatal adverse reactions occurred in 1.8% of patients who received Inluriyo, including cardiac arrest, acute myocardial infarction, right ventricular failure, hypovolemic shock, and upper gastrointestinal hemorrhage (each 0.3%).

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥10%), including laboratory abnormalities, in patients who received Inluriyo were: hemoglobin decreased (30%), musculoskeletal pain (30%), calcium decreased (26%), neutrophils decreased (26%), AST increased (25%), fatigue (23%), diarrhea (22%), ALT increased (21%), triglycerides increased (21%), nausea (17%), platelets decreased (16%), constipation (10%), cholesterol increased (10%), and abdominal pain (10%).

Drug Interactions

Imlunestrant is a CYP3A substrate. Avoid concomitant use of Inluriyo with strong CYP3A inhibitors. If concomitant use cannot be avoided, reduce the dosage of Inluriyo. Avoid concomitant use of Inluriyo with strong CYP3A inducers. If concomitant use cannot be avoided, increase the dosage of Inluriyo.

Imlunestrant inhibits both P-gp and BCRP. Avoid concomitant use unless otherwise recommended in the Prescribing Information for P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions.

Use in Specific Populations - Lactation

Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Use in Specific Populations - Hepatic Impairment

Reduce the dose of Inluriyo for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. No dosage adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A).

Inluriyo (imlunestrant) is available as 200 mg tablets.

Please click to access Prescribing Information for Inluriyo.

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