Eli Lilly and Company — Inluriyo EMA EPAR public assessment report (EMEA/H/C/006184, 2026)
Eli Lilly and Company · 2026 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted a positive opinion for Eli Lilly's Inluriyo (imlunestrant) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. Indicated as monotherapy and in combination with abemaciclib, Inluriyo is an orally bioavailable selective estrogen receptor degrader (SERD). Preclinical studies demonstrated potent anti-tumor activity and a well-characterized pharmacokinetic profile. The pivotal EMBER-3 study showed significant improvement in progression-free survival (PFS) and a trend towards improved overall survival (OS) in the ESR1-mutated population with imlunestrant monotherapy. The combination with abemaciclib further enhanced PFS. Common adverse events included gastrointestinal issues and elevated transaminases, with a manageable safety profile.
Key findings — cited to the page
| Grade ≥3 TEAEs (SOC) | 20.7 % | EMBER-3 study · p.210 |
| Grade ≥3 Diarrhoea (SOC) | 0 % | EMBER-3 study · p.212 |
| Grade ≥3 TEAEs (imlunestrant) | 17.1 % | EMBER-3 study · p.210 |
| Grade ≥3 Transaminases increased (SOC) | 1.2 % | EMBER-3 study · p.212 |
| Prevalence-adjusted NPV (ESR1m prevalence 0.37) | 97.4 % | OncoCompass Plus · p.144 |
| Grade ≥3 Diarrhoea (imlunestrant + abemaciclib) | 8.2 % | EMBER-3 study · p.212 |
| Grade ≥3 Nausea (imlunestrant) | 0.3 % | EMBER-3 study · p.212 |
| Grade ≥3 AEs (SOC) | 20.7 % | EMBER-3 study · p.212 |
| Grade ≥3 Transaminases increased (imlunestrant) | 1.2 % | EMBER-3 study · p.212 |
| Grade ≥3 Transaminases increased (imlunestrant + abemaciclib) | 5.3 % | EMBER-3 study · p.212 |
| Grade ≥3 Diarrhoea (imlunestrant) | 0.3 % | EMBER-3 study · p.212 |
| Grade ≥3 AEs (imlunestrant) | 17.1 % | EMBER-3 study · p.212 |
Source: Eli Lilly and Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →