Roche Reports Positive Phase III Results For Giredestrant Plus Everolimus In Advanced ER+ Breast Cancer

Roche reported positive topline results from the phase III evERA trial, which evaluated investigational giredestrant in combination with everolimus for patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer who had previously received CDK4/6 inhibitors and endocrine therapy.

The trial achieved both co-primary endpoints, showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the overall study population and in patients with ESR1 mutations, compared to the standard-of-care endocrine therapy plus everolimus. While overall survival (OS) data remain immature, early results indicate a positive trend, and further follow-up is ongoing. The treatment was generally well tolerated, with a safety profile consistent with existing knowledge of the drugs, and no new safety concerns emerged. Importantly, this is the first positive phase III head-to-head study of an all-oral SERD (selective oestrogen receptor degrader)-based regimen against standard care.

“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. 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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

ER-positive breast cancer represents around 70% of all breast cancer cases, yet resistance to endocrine therapies, especially after CDK inhibitor treatment, continues to present major challenges and poor outcomes. By targeting two distinct pathways, the giredestrant plus everolimus combination has the potential to improve outcomes while offering the convenience of an all-oral regimen. Roche plans to submit the evERA data to regulatory authorities with the goal of making this new treatment option available to patients as soon as possible.