Overview
- Updated Phase 3 EMBER-3 results were published in Annals of Oncology and presented at SABCS for previously treated ER-positive, HER2-negative advanced or metastatic breast cancer.
- In patients with ESR1-mutated disease, imlunestrant monotherapy cut the risk of progression or death by 38% versus standard endocrine therapy and delivered a median overall survival of 34.5 months versus 23.1 months.
- Across all patients, adding abemaciclib to imlunestrant reduced progression or death by 41% versus imlunestrant alone, nearly doubled median progression-free survival to 10.9 months from 5.5 months, and extended median time to chemotherapy to 27.8 months from 15.5 months.
- Benefits with the combination were seen regardless of ESR1 mutation status, including after prior CDK4/6 inhibitor use where median progression-free survival reached 9.1 months versus 3.7 months with imlunestrant alone, while overall survival follow-up continues with no new safety signals reported.
- The imlunestrant program also includes the fully enrolled ~8,000-patient EMBER-4 adjuvant trial; the FDA previously approved single-agent imlunestrant for ESR1-mutated advanced disease, and Lilly shares rose about 1.3% on the update.