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of patients will develop ESR1-mutated MBC during treatment with an AI.3

ESR1 mutations are a key driver of metastatic disease progression and are associated with aggressive biology that can lead to worse clinical outcomes.4

AI=aromatase inhibitor; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; HER2–=human epidermal growth factor receptor 2-negative; MBC=metastatic breast cancer.

National Comprehensive Cancer Network® (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.5

ctDNA=circulating tumor DNA; ESR1=estrogen receptor-1; ET=endocrine therapy; NCCN=National Comprehensive Cancer Network; NGS=next-generation sequencing; PCR=polymerase chain reaction.

ACT post AI: Assess, Confirm, Treat1,2,6

ACT=assess, confirm, treat; AI=aromatase inhibitor; ESR1=estrogen receptor-1; FDA=U.S. Food and Drug Administration.

References:

  1. Inluriyo. Prescribing Information. Lilly USA, LLC.
  2. Verzenio. Prescribing Information. Lilly USA, LLC.
  3. 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
  4. Chandarlapaty S, Chen D, He W, et al. Prevalence of ESR1 mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial. JAMA Oncol. 2016;2(10):1310-1315. doi:10.1001/jamaoncol.2016.1279
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V6.2026. ©National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed Aug 19, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.
  6. 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

CMAT-31279 09/2026

Indications

Inluriyo® in combination with Verzenio® 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy1,2

Inluriyo monotherapy 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, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy1

IMPORTANT SAFETY INFORMATION FOR INLURIYO® (imlunestrant) AS MONOTHERAPY IN COMBINATION WITH VERZENIO® (abemaciclib)

Diarrhea: Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. In EMBER-3, diarrhea occurred in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 diarrhea occurred in 9%. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Neutropenia: Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. In EMBER-3, neutrophil count decreased in 86% of patients who received Inluriyo in combination with Verzenio; Grade 3 or 4 decreases occurred in 21%. Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. In EMBER-3, ILD or pneumonitis occurred in 2.9% of patients who received Inluriyo in combination with Verzenio. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with Verzenio. Monitor LFTs every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated with Verzenio. Monitor ALT and AST during treatment with Inluriyo as clinically indicated. In EMBER-3, ALT increase occurred in 33% for all grades (Grade 3 or 4: 5%) and AST increase occurred in 36% for all grades (Grade 3 or 4: 2.5%) of patients who received Inluriyo in combination with Verzenio. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Venous Thromboembolism: Deaths due to venous thromboembolism have been reported in patients treated with Verzenio. In EMBER-3, venous thromboembolic events occurred in 4.8% of patients who received Inluriyo in combination with Verzenio. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Follow specific dose modification and management instructions located in the Prescribing Information for each drug.

Embryo-Fetal Toxicity: Inluriyo and Verzenio 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. Verify pregnancy status in females of reproductive potential prior to initiating treatment. Advise females of reproductive potential to use effective contraception during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of Inluriyo.

For Inluriyo monotherapy, 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.

Increased Serum Creatinine Without Affecting Renal Function: Verzenio can increase serum creatinine. These increases were not associated with changes in glomerular function. In EMBER-3, creatinine increase occurred in 36% for all grades (Grade 3 or 4: 1.1%) of patients who received Inluriyo in combination with Verzenio. During Verzenio treatment, use alternative measures that are not based on serum creatinine to assess renal function, such as BUN, cystatin C, or calculated GFR.

Serious and Fatal Adverse Reactions for Inluriyo in Combination with Verzenio: Serious adverse reactions occurred in 21% of patients who received Inluriyo in combination with Verzenio. Serious adverse reactions in >1% of patients who received Inluriyo in combination with Verzenio included pneumonia (2.4%), abdominal pain, and renal failure (each 1.4%). Fatal adverse reactions occurred in 3.8% of patients who received Inluriyo in combination with Verzenio, including pneumonia (1.4%), myocardial infarction, interstitial lung disease, and sepsis (0.5% each).

Most Common Adverse Reactions for Inluriyo in Combination with Verzenio: The most common (≥10%) adverse reactions with Inluriyo in combination with Verzenio, including laboratory abnormalities, were decreased neutrophils, diarrhea, decreased hemoglobin, decreased lymphocytes, nausea, decreased platelets, fatigue, increased triglycerides, infections, increased AST, increased creatinine, increased ALT, vomiting, musculoskeletal pain, abdominal pain, decreased appetite, increased cholesterol, rash, cough, headache, and decreased weight.

Serious and Fatal Adverse Reactions for Inluriyo Monotherapy: 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 for Inluriyo Monotherapy: The most common (≥10%) adverse reactions with Inluriyo monotherapy, including laboratory abnormalities were decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.

Drug Interactions – Inluriyo:

  • Avoid concomitant use with strong CYP3A inhibitors. If concomitant use cannot be avoided, decrease the Inluriyo dosage. Avoid concomitant use with strong CYP3A inducers. If concomitant use cannot be avoided, increase the Inluriyo dosage. See Prescribing Information for recommended dosage modifications.
  • 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.

Drug Interactions – Verzenio:

  • CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the Verzenio dose with concomitant use of other strong and moderate CYP3A inhibitors. Monitor for adverse reactions and follow the specific dose modification instructions located in the Prescribing Information. Patients should avoid grapefruit products.
  • CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers and consider alternative agents.

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Inluriyo in combination with Verzenio and for 3 weeks after the last dose of Verzenio or 1 week after the last dose of Inluriyo, whichever is longer.

For Inluriyo monotherapy, advise lactating women to not breastfeed during treatment with Inluriyo and for 1 week after the last dose.

Hepatic Impairment: With Inluriyo, reduce the dose in patients with moderate or severe hepatic impairment. The recommended dosage for patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment is 200 mg once daily. No dosage modification is recommended for patients with mild hepatic impairment (Child-Pugh A).

With Verzenio, reduce the dosing frequency to once daily in patients with severe hepatic impairment (Child-Pugh C). No dosage adjustments are necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).

Infertility: Inluriyo may impair fertility in females and males of reproductive potential.

Verzenio may impair fertility in males of reproductive potential.

Inluriyo (imlunestrant) is available as 200 mg tablets.

Verzenio (abemaciclib) is available as 50 mg, 100 mg, 150 mg, and 200 mg tablets.

Please click to access Prescribing Information Inluriyo and Verzenio.

IN VZ HCP ISI Combo+Mono APPR

Inluriyo® and Verzenio® are registered trademarks and Lilly Support Services™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.