EMBER-3

NCT04975308 📎

Regimen

Experimental
Imlunestrant 400 mg daily (oral SERD) monotherapy; or imlunestrant plus abemaciclib 150 mg BID (triplet).
Control
Standard-of-care endocrine monotherapy (fulvestrant or exemestane).

Population

Men and women with HR+/HER2- advanced breast cancer who had progressed on or after prior AI (with or without CDK4/6 inhibitor); stratified by ESR1 mutation status and prior CDK4/6 exposure.

Key finding

EMBER-3 showed imlunestrant benefit over SOC in ESR1-mutant disease and significant PFS gain when imlunestrant is combined with abemaciclib, regardless of ESR1 status. NCCN v2.2026 BINV-P adds imlunestrant + abemaciclib as an option in 2L+, most useful in ESR1-mutant disease without prior CDK4/6 exposure.

Source: PMID 39660834

Timeline

  • Publication: 2025 Mar 27

Guideline citations

  • NCCN BREAST