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

​​In ER+, HER2−, ESR1-mutated MBC

​​Inluriyo is NOW APPROVED

A new oral option for patients¹

EMBER-3: A global Phase 3 trial in patients with ER+, HER2− MBC who are post AI (N=874)^1,2 ​

256 patients had ESR1m MBC (Arm A: n=138, Arm B: n=118)^1,2

​​Designed to test Inluriyo PFS vs fulvestrant or exemestane^1,2

^aIncludes SERDs, chemotherapy, or PI3K pathway inhibitors.²

^bPatients were treated until disease progression or unacceptable toxicity.¹

^cIn a plasma specimen using an FDA-approved test.¹

^dOne patient was randomized to Arm B and did not receive drug (fulvestrant).¹

Primary endpoints^1,2

• PFS by investigator assessment in Arm A vs Arm B in the ITT population
• PFS by investigator assessment in Arm A vs Arm B in the ESR1m population

Secondary endpoints^1,2

• OS
• BIRC-assessed PFS
• ORR
• Safety

In patients with ER+, HER2−, ESR1m MBC (n=256)¹

Inluriyo provided superior PFS benefit vs fulvestrant or exemestane¹

Investigator-assessed PFS in patients with ESR1m MBC¹

​​Inluriyo led to a 38% reduction in the risk of progression or death.¹​

Primary endpoint was met: 5.5 months mPFS with Inluriyo (n=138) vs 3.8 months mPFS with fulvestrant (n=111) or exemestane (n=6) (HR=0.62 [95% CI: 0.46-0.82]); P=0.0008.¹*

*One patient was randomized to Arm B and did not receive drug (fulvestrant).¹

AI=aromatase inhibitor; BIRC=blinded independent review committee; CDK4/6i=cyclin-dependent kinase 4 and 6 dual inhibitor; CI=confidence interval; ER+=estrogen receptor‐positive; ESR1=estrogen receptor 1; ESR1m=estrogen receptor 1‐mutated; ET=endocrine therapy; FDA=Food and Drug Administration; HER2−=human epidermal growth factor receptor 2‐negative; HR=hazard ratio; ITT=intent-to-treat; MBC=metastatic breast cancer; mPFS=median progression-free survival; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PI3K=phosphatidylinositol 3-kinase; R=randomization; SERD=selective estrogen receptor degrader.

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.

IN HCP ISI M APP

Reference(s):

1. Inluriyo. Prescribing Information. Lilly USA, LLC.

2. Jhaveri KL, Neven P, Casalnuovo ML, et al. Imlunestrant with or without abemaciclib in advanced breast cancer. N Engl J Med. 2025;392(12):1189-1202. doi:10.1056/NEJMoa2410858