# EMBER-3

Source: https://onco.cc/trials/ember-3/  
OnCo record `ember-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An oral SERD that works alone in ESR1-mutant tumours and, combined with abemaciclib, doubles progression-free time in everyone regardless of mutation.

## Summary

Three arms (imlunestrant n=331; standard ET n=330; imlunestrant + abemaciclib n=213). In ESR1-mutant tumours imlunestrant alone: PFS 5.5 vs 3.8 months (HR 0.62). Imlunestrant + abemaciclib vs imlunestrant: PFS 9.4 vs 5.5 months (HR 0.57; updated 10.9 vs 5.5, HR 0.59), with benefit irrespective of ESR1 status. Updated analysis (SABCS 2025): ESR1-mutant OS 34.5 vs 23.1 months for monotherapy vs standard ET. FDA approved imlunestrant (Inluriyo) 25 September 2025 for ESR1-mutant disease.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT04975308
- Phase: 3
- Setting: ER+/HER2- advanced breast cancer after ≥1 endocrine line: imlunestrant vs standard endocrine therapy, and imlunestrant + abemaciclib vs imlunestrant
- Sponsor: Eli Lilly
- Enrolled: 874
- Result: PFS HR 0.62 (ESR1-mutant, monotherapy); HR 0.57 (combination vs monotherapy).
- Outcomes: Progression-free survival, ESR1-mutant (imlunestrant vs standard ET): Imlunestrant 5.5 months vs Standard endocrine therapy 3.8 months, HR 0.62; Progression-free survival (imlunestrant + abemaciclib vs imlunestrant): Imlunestrant + abemaciclib 10.9 months vs Imlunestrant 5.5 months, HR 0.59; Overall survival, ESR1-mutant (imlunestrant vs standard ET), updated: Imlunestrant 34.5 months vs Standard endocrine therapy 23.1 months
- Replication: Monotherapy effect consistent with EMERALD and VERITAC-2; the combination result is the first randomised evidence for oral SERD + CDK4/6 after prior CDK4/6 exposure.

## Sources

- ClinicalTrials.gov NCT04975308: https://clinicaltrials.gov/study/NCT04975308
- Lilly approval release: https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-adults-er-her2-esr1

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/)
- targets: [CDK4/6](https://onco.cc/targets/cdk4-6/), [Estrogen receptor (ERα)](https://onco.cc/targets/estrogen-receptor/)
- drugs: [Abemaciclib](https://onco.cc/drugs/abemaciclib/), [Imlunestrant](https://onco.cc/drugs/imlunestrant/)
- companies: [Eli Lilly (incl. Loxo)](https://onco.cc/companies/eli-lilly/)
- terms: [ESR1 mutation](https://onco.cc/terms/esr1-mutation/), [Oral SERD](https://onco.cc/terms/oral-serd/)
- people: [Komal Jhaveri](https://onco.cc/people/komal-jhaveri/)
- key papers: [Imlunestrant with or without Abemaciclib in Advanced Breast Cancer](https://onco.cc/key-papers/paper-ember-3-n-engl-j-med-2025/)
- pairings: [Oral SERD + CDK4/6 inhibitor after ESR1 emergence](https://onco.cc/pairings/oral-serd-plus-cdk46-after-esr1/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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