Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-Positive Advanced Breast Cancer

evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus

The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed

evERA is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination

Data will be presented at an upcoming medical meeting and shared with health authorities

Excerpt from the Press Release:

South San Francisco, CA — September 21, 2025 —

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen 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 co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. Overall survival (OS) data were immature, but a clear positive trend was observed. Follow-up continues to the next OS analysis. The giredestrant combination was well tolerated. Adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were observed. This is the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus a standard of care combination. 

“These results show that the giredestrant combination provides a meaningful benefit for ER-positive breast cancer patients whose disease has progressed following treatment with a CDK inhibitor,” said Levi Garraway, M.D., Ph.D., 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.”   

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