By: IPP Bureau
Last updated : September 23, 2025 12:32 pm
Importantly, the combination of giredestrant and everolimus was well tolerated
Roche announced positive results from the Phase III evERA study, which evaluated investigational giredestrant in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy.
The study met both of its co-primary endpoints, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat (ITT) population and the ESR1-mutated subgroup, compared with standard-of-care endocrine therapy plus everolimus. While overall survival (OS) data remain immature, a clear positive trend was observed, and follow-up is ongoing for the next OS analysis.
Importantly, the combination of giredestrant and everolimus was well tolerated. Adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were identified. The evERA trial represents the first positive head-to-head Phase III study to investigate an all-oral selective oestrogen receptor degrader (SERD)-containing regimen versus a standard-of-care combination.
“These results show that the giredestrant combination provided a meaningful benefit for ER-positive breast cancer patients whose disease has progressed following treatment with a CDK inhibitor,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to discussing these results with regulatory authorities with the goal of making this giredestrant-based regimen available to many people with advanced ER-positive breast cancer.”
Roche’s extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting the company’s commitment to delivering innovative medicines to as many people with ER-positive breast cancer as possible.
Data from the evERA study will be presented at an upcoming medical meeting and submitted to health authorities worldwide, with the aim of making this new treatment option available to patients as quickly as possible.