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Updated data for Lilly's Inluriyo™ (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio® (abemaciclib) in ER+, HER2- advanced breast cancer
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
About this update from Eli Lilly And Company
[{"type":"text","content":"As monotherapy, imlunestrant demonstrated an 11.4-month numeric improvement in median OS versus endocrine therapy in patients with ESR1-mutated disease","length":151,"tagName":"p","attribs":{}},{"type":"text","content":"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","length":189,"tagName":"p","attribs":{}},{"type":"text","content":"These data were published simultaneously in Annals of Oncology and will be presented today at the 2025 San Antonio Breast Cancer Symposium","length":138,"tagName":"p","attribs":{}},{"type":"text","content":"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.","length":1094,"tagName":"p"},{"type":"text","content":"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.","length":215,"tagName":"p","attribs":{}},{"type":"text","content":""Following the recent FDA approval of Inluriyo as monotherapy, these updated data demonstrate continued clinically meaningful benefit—both for patients receiving monotherapy and those receiving the combination with abemaciclib—and further reinfo...