Lilly Reports Positive Phase 3 EMBER-3 Results For Inluriyo In Advanced Breast Cancer

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(RTTNews) - Eli Lilly and Company (LLY) announced updated results from the Phase 3 EMBER-3 study evaluating 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). The study focused on patients whose disease had progressed following prior treatment with an aromatase inhibitor, with or without a CDK4/6 inhibitor.

As monotherapy, imlunestrant demonstrated a 38% reduction in the risk of progression or death and an 11.4-month improvement in median overall survival (OS) compared with endocrine therapy in patients with ESR1-mutated disease. In all patients, the combination of imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, showed a favorable OS trend, and delayed time to chemotherapy (TTC) by more than a year.

Results for the imlunestrant and abemaciclib combination were consistent with prior findings, showing durable benefit across efficacy endpoints regardless of ESR1 mutation status. Median progression-free survival (PFS) was nearly doubled compared with imlunestrant alone, and median TTC was extended by more than a year. In patients with ESR1-mutated disease, median PFS reached 11.0 months versus 5.6 months with imlunestrant alone. Notably, 65% of patients in the combination arm had previously received a CDK4/6 inhibitor.

Safety across imlunestrant-based regimens remained consistent with earlier reports, with no new safety signals observed. Follow-up for OS is ongoing, and further analyses are planned as data mature.

In addition to EMBER-3, imlunestrant is being investigated in the adjuvant setting for patients with ER+, HER2- early breast cancer at increased risk of recurrence. The Phase 3 EMBER-4 trial has completed enrollment of approximately 8,000 patients following two to five years of adjuvant endocrine therapy within the established CDK4/6 inhibitor standard of care.

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