Eli Lilly Reports Inluriyo Shows Major Survival Gains In ESR1-Mutated Breast Cancer And Strong Combo Benefits With Abemaciclib In Phase 3 EMBER-3 Study; Results Published In Annals of Oncology Ahead Of SABCS Presentation

As monotherapy, imlunestrant demonstrated an 11.4-month numeric improvement in median OS versus endocrine therapy in patients with ESR1-mutated disease

In all patients, the imlunestrant plus abemaciclib combination achieved a median PFS of 10.9 months, demonstrated a favorable OS trend, and extended time to chemotherapy by more than a year

These data were published simultaneously in Annals of Oncology and will be presented today at the 2025 San Antonio Breast Cancer Symposium

INDIANAPOLIS, Dec. 12, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) today announced updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant), an oral estrogen receptor antagonist, in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer (MBC), whose disease progressed on a prior aromatase inhibitor (AI), with or without a CDK4/6 inhibitor. As monotherapy, imlunestrant demonstrated a clinically meaningful 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62 [95% CI 0.47–0.82]; nominal p=0.0007) and demonstrated an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60 [95% CI 0.43–0.86]; p=0.0043; boundary for significance not met) versus endocrine therapy, in patients with ESR1-mutated disease. In all patients, imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, demonstrated a favorable OS trend and numerically delayed time to chemotherapy (TTC) by more than a year.

These results were published in Annals of Oncology and will be shared in a late-breaking oral presentation at the San Antonio Breast Cancer Symposium (SABCS) today, Friday, December 12, at 10:45 AM CT / 11:45 AM ET.