Lilly:Inluriyo ™ (imlunestrant)received marketing approval

On June 22, the NMPA official website showed that Eli Lilly’s Category 1 new drug Imlunestrant Tablets have been approved for marketing in China, with the following indications: as monotherapy for adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutant locally advanced or metastatic breast cancer who have received prior endocrine therapy; and in combination with abemaciclib for adult patients with ER-positive, HER2-negative, ESR1-mutant locally advanced or metastatic breast cancer who have received prior endocrine therapy.

Imlunestrant is an oral estrogen receptor (ER) antagonist that continuously suppresses ER activity, including in tumors with ESR1 mutations. The estrogen receptor is a key therapeutic target in ER+/HER2- breast cancer. Novel ER degraders have the potential to overcome endocrine therapy resistance while providing stable oral pharmacological properties and convenient dosing.

In December 2025, Eli Lilly presented the latest results from the EMBER-3 clinical trial in an oral presentation at the San Antonio Breast Cancer Symposium (SABCS). The data showed that compared with endocrine therapy, Imlunestrant monotherapy demonstrated a clinically meaningful 38% reduction in the risk of disease progression or death in patients with ESR1 mutations (median progression-free survival [PFS]: 5.5 months vs 3.8 months; HR=0.62), with a median overall survival (OS) prolongation of 11.4 months (34.5 months vs 23.1 months; HR=0.60).

The results for Imlunestrant in combination with abemaciclib were consistent with previous efficacy data, demonstrating durable benefit across all efficacy endpoints regardless of ESR1 mutation status. In all patients, the median PFS in the Imlunestrant plus abemaciclib arm was nearly double that of the Imlunestrant monotherapy arm (10.9 months vs 5.5 months; HR=0.59), with a favorable trend in OS (HR=0.82) and sustained separation of the survival curves. Compared with the Imlunestrant monotherapy arm, the median time to chemotherapy (TTC) in the Imlunestrant plus abemaciclib arm was numerically delayed by more than one year (27.8 months vs 15.5 months). In patients with ESR1 mutations, Imlunestrant plus abemaciclib extended median PFS to 11.0 months, compared with 5.6 months in the Imlunestrant monotherapy arm (HR=0.55).

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