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Investigator-assessed PFS in patients with ESR1m MBC1,2

Inluriyo + Verzenio was associated with a 47% reduction in the risk of progression or death, based on the hazard ratio of 0.53, compared to Inluriyo.1

This prespecified subgroup analysis was not error controlled.1,3

CI=confidence interval; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; ESR1m=estrogen receptor-1-mutated; HER2–=human epidermal growth factor receptor 2-negative; HR=hazard ratio; MBC=metastatic breast cancer; mPFS=median progression-free survival; PFS=progression-free survival.

Inluriyo + Verzenio Response1-3

a Objective response rate (ORR) = CR + PR per RECIST v1.1 in patients with measurable disease.1,3

b ORR 35% (n=54) (95% CI: 22-48).1

c ORR: 15% (n=74) (95% CI: 7-23).1

This prespecified subgroup analysis was not error controlled.1,3

CI=confidence interval; CR=complete response; ORR=objective response rate; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors.

SELECT IMPORTANT SAFETY INFORMATION — 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.

In patients with post-AI ER+, HER2–, ESR1m MBC

Inluriyo monotherapy provided superior PFS benefit vs fulvestrant or exemestane1

Inluriyo

5.5 months mPFS

with Inluriyo (n=138)

vs

3.8 months mPFS

with fulvestrant or exemestane (n=118)

HR=0.62 (95% CI: 0.46–0.82); P=0.0008

Inluriyo was associated with a 38% reduction in the risk of progression or death, based on the hazard ratio of 0.62, compared to fulvestrant or exemestane.1

AI=aromatase inhibitor; CI=confidence interval; ER+=estrogen receptor-positive; ESR1m=estrogen receptor-1-mutated; HER2–=human epidermal growth factor receptor 2-negative; HR=hazard ratio; MBC=metastatic breast cancer; mPFS=median progression-free survival; PFS=progression-free survival.

OS with Inluriyo vs fulvestrant or exemestane1,2

At the time of this prespecified interim analysis, 50% of deaths had occurred in the ESR1m population3,4

a Median follow-up was 29.5 months.3

This prespecified interim efficacy analysis (data cut off: 18 August 2025) was triggered after ~255 OS events had occurred among patients in the imlunestrant and fulvestrant or exemestane arms.4

At the time of FDA approval of Inluriyo monotherapy, overall survival data were immature with 31% of deaths in the ESR1m population.1

At the time of interim analysis, OS data for Inluriyo + Verzenio were immature, with 35% of deaths in the ESR1m population.1,2

CI=confidence interval; ESR1m=estrogen receptor-1–mutated; HR=hazard ratio; mOS=median overall survival; OS=overall survival.

SELECT IMPORTANT SAFETY INFORMATION — 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.

EMBER-3: A global Phase 3 trial of Inluriyo in patients with ER+, HER2– MBC who have progressed post AI (N=874)1,2

Inluriyo monotherapy was approved based on the ESR1m population on Inluriyo and fulvestrant or exemestane (n=256). Inluriyo + Verzenio combination was approved based on a prespecified subgroup analysis of concurrently enrolled ESR1m population on Inluriyo + Verzenio and Inluriyo (n=159).1-3

Designed to test Inluriyo as monotherapy and in combination with Verzenio1-3

aIncludes ER antagonists, chemotherapy, or PI3K pathway inhibitors.3

bPatients were treated until disease progression or unacceptable toxicity.1,3

cIn a plasma specimen using an authorized test.1

dThis is referred to as major efficacy outcomes for PFS of Inluriyo and Inluriyo + Verzenio in the ESR1m population.1,2

eThis is referred to as other efficacy outcomes for OS and ORR of Inluriyo and Inluriyo + Verzenio in the ESR1m population.1,2

AI=aromatase inhibitor; CDK4/6i=cyclin-dependent kinase 4 and 6 dual inhibitor; ER+=estrogen receptor-positive; ESR1m=estrogen receptor-1-mutated; ET=endocrine therapy; HER2–=human epidermal growth factor receptor 2-negative; ITT=intent-to-treat; MBC=metastatic breast cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PI3K=phosphatidylinositol-3 kinase; R=randomized.

In ER+, HER2–, ESR1m MBC

Inluriyo + Verzenio was studied across a range of patients1-3,5

circular badge icon showing one hundred percent prior ai therapy

Prior therapy for Inluriyo + Verzenio3,5

Baseline demographics and characteristics in EMBER-31-3,5a

aPercentages may not total 100 because of rounding.3

b92 people appear in both Inluriyo arms.4

cPI3K pathway mutations included single nucleotide variants and insertions or deletions in the genes PIK3CA, AKT1, or PTEN as analyzed by Guardant360 ctDNA assay.3

dPrior endocrine therapy for 1L patients was in the adjuvant setting; prior endocrine therapy for 2L patients was in the advanced setting.3

1L=first line; 2L=second line; AI=aromatase inhibitor; AKT1=protein kinase B alpha gene; CDK4/6i=cyclin-dependent kinase 4 and 6 dual inhibitor; ctDNA=circulating tumor DNA; ER+=estrogen receptor-positive; ESR1=estrogen receptor-1; ESR1m=estrogen receptor-1-mutated; ET=endocrine therapy; HER2–=human epidermal growth factor receptor 2-negative; MBC=metastatic breast cancer; PI3K=phosphatidylinositol-3 kinase; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene; PTEN=phosphatase and tensin homolog gene.

References:

  1. Inluriyo. Prescribing Information. Lilly USA, LLC.
  2. Verzenio. Prescribing Information. Lilly USA, LLC.
  3. Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025;392(12)(Incl suppl mat + protocol):1189-1202. doi:10.1056/NEJMoa2410858
  4. Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer: updated efficacy results from the phase III EMBER-3 trial. Ann Oncol. 2025;Epub(Incl suppl mat). doi:10.1016/j.annonc.2025.11.018
  5. Data on File. CREF-1063. Lilly USA, LLC.

CMAT-31274 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.