- evERA met co-primary endpoints in ITT and ESR1-mutated populations.
- The study involved giredestrant and everolimus in ER-positive breast cancer.
- No new safety signals were observed in the all-oral combination.
- Data will be presented at an upcoming medical meeting.
Study Overview
The phase III evERA study evaluated the combination of giredestrant and everolimus in patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer. These patients had previously been treated with CDK 4/6 inhibitors and endocrine therapy.
Key Findings
The study met its co-primary endpoints, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both the intention-to-treat and ESR1-mutated populations compared to standard-of-care endocrine therapy plus everolimus. Although overall survival (OS) data were immature, a positive trend was noted, and follow-up is ongoing for further OS analysis.
Safety Profile
The all-oral combination of giredestrant and everolimus was well tolerated, with adverse events aligning with the known safety profiles of the individual treatments. No new safety signals were identified during the study.
Future Steps
Data from the evERA study will be presented at an upcoming medical meeting and shared with health authorities. This trial marks the first positive head-to-head phase III investigation of an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination.
