Lilly(US:LLY) Prnewswire·2025-12-12 16:45Core Insights - Imlunestrant (Inluriyo) shows significant clinical benefits in treating ER+ HER2- advanced or metastatic breast cancer, with an 11.4-month improvement in median overall survival (OS) compared to endocrine therapy in patients with ESR1 mutations [1][3] - The combination of imlunestrant and abemaciclib resulted in a median progression-free survival (PFS) of 10.9 months and extended time to chemotherapy by over a year [1][3] - The updated data from the Phase 3 EMBER-3 study reinforces the role of imlunestrant in this treatment setting, with ongoing regulatory review for the combination therapy [3][4] Study Results - As monotherapy, imlunestrant achieved a 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62) and an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60) in ESR1-mutated patients [1][3] - The combination therapy reduced the risk of progression or death by 41% compared to imlunestrant alone, with a median PFS of 10.9 months [1][3] - In patients with ESR1 mutations, median PFS was extended to 11.0 months with the combination therapy [3][4] Safety and Efficacy - Safety profiles for imlunestrant-based regimens were consistent with previous reports, with no new safety signals observed [4] - Most patients (65%) in the combination arm had previously received a CDK4/6 inhibitor, indicating a durable benefit across efficacy endpoints [3][4] - Follow-up for OS is ongoing, with additional analyses planned as data mature [4] Future Directions - Imlunestrant is also being investigated in the adjuvant setting for ER+ HER2- early breast cancer with increased recurrence risk, with the EMBER-4 trial enrolling approximately 8,000 patients [5][6] - The ongoing studies aim to further establish the efficacy and safety of imlunestrant in various treatment settings [5][6]