Eli Lilly and Co. (NYSE:LLY) on Friday shared updated results from the Phase 3 EMBER-3 study of Inluriyo (imlunestrant) for previously treated breast cancer patients.

The trial included 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 progression-free survival 5.5 vs 3.8 months) and demonstrated an 11.4-month improvement in median overall survival (34.5 vs 23.1 months) versus endocrine therapy, in patients with ESR1-mutated disease.

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In all patients, imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, demonstrated a favorable overall survival trend, and numerically delayed time to chemotherapy (TTC) by more than a year.

Data Presented At Major Oncology Meeting

These results were published in Annals of Oncology and will be shared at the San Antonio Breast Cancer Symposium (SABCS).

Results for the imlunestrant plus abemaciclib combination were consistent with previous efficacy results and demonstrated durable benefit across efficacy endpoints, regardless of ESR1 mutation status.

In all patients, median progression-free survival was nearly doubled versus imlunestrant alone (10.9 vs 5.5 months), and a favorable overall survival trend was observed.

Median TTC was numerically extended by more than a year (27.8 vs 15.5 months) versus imlunestrant alone.

In patients with ESR1-mutated disease, median progression-free survival was extended to 11.0 months versus 5.6 months with imlunestrant alone.

Ongoing Follow-Up And Additional Analyses

Follow-up for overall survival is ongoing, and additional analyses are planned as data mature.

Imlunestrant is also being investigated in the adjuvant setting in people with ER+, HER2– early breast cancer with an increased risk of recurrence.

The Phase 3 EMBER-4 trial completed enrollment of approximately 8,000 patients following two to five years of adjuvant endocrine therapy in the context of the established CDK4/6i standard of care.

LLY Price Action: Eli Lilly shares were up 1.26% at $1022.09 at the time of publication on Friday, according to Benzinga Pro data.

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