Stemline B V — Orserdu EMA EPAR public assessment report (EMEA/H/C/005898, 2023)
Stemline B V · 2023 · EMA EPAR public assessment report
Report summary
The EMA assessed Orserdu (elacestrant) for marketing authorization, granting a positive opinion for its use in postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer with an activating ESR1 mutation, who have progressed after at least one line of endocrine therapy including a CDK4/6 inhibitor. Preclinical studies demonstrated elacestrant's potent ER antagonist and degrader activity, showing anti-tumor efficacy in various ER-positive breast cancer models, including those with ESR1 mutations and CDK4/6 inhibitor resistance, with a favorable safety profile in animal models. Clinical trials, particularly the pivotal Phase 3 EMERALD study, confirmed statistically significant improvement in progression-free survival (PFS) for elacestrant, especially in the ESR1-mutated subgroup, leading to the restricted indication. While overall survival (OS) differences were not statistically significant, the drug's efficacy in ESR1-mutated patients supported its approval.
Key findings — cited to the page
| photo irritation factor for elacestrant | 1.118 | · p.63 |
| PFS p-value for elacestrant vs AI in ESR1-mut patients with prior fulvestrant | 0.3465 | Study 308 · p.140 |
| 5-year survival probability for early breast cancer | ~96% | Europe · p.10 |
| Median OS in SOC group (ESR1-mut subjects) | 16.95 months | Study 308 · p.121 |
| overall survival HR (95% CI) | 0.912 (0.708-1.175) | Study 308 · p.122 |
| PFS HR (95% CI) for elacestrant vs AI in ESR1-mut patients with prior fulvestrant | 0.705 (0.334 - 1.447) | Study 308 · p.140 |
| Estimated breast cancer deaths in EU | 157,100 | EU · p.10 |
| 5-year survival rate for metastatic breast cancer | 38% | · p.10 |
| percentage of SOC group subjects discontinued treatment (ESR1-mut) | 91.2 % | · p.103 |
| OS p-value (ESR1-mut subjects) | 0.0325 | Study 308 · p.119 |
| median overall survival (months) | 22.57 months | Study 308 · p.122 |
| median overall survival (months) | 24.61 months | Study 308 · p.122 |
Source: Stemline B V ↗ · 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 →