Genentech's Giredestrant Combo Shows Strong Phase III Results In Advanced Breast Cancer Trial

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(RTTNews) - Genentech, a member of the Roche Group (RHHBY), announced positive results from the Phase III evERA Breast Cancer study. The data revealed that giredestrant in combination with everolimus significantly reduced the risk of disease progression or death—known as progression-free survival (PFS)—by 44% in the intention-to-treat (ITT) population and by 62% in the ESR1-mutated population, compared to standard-of-care endocrine therapy plus everolimus.

The evERA study is evaluating this investigational combination in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. All participants had previously been treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor and endocrine therapy.

The giredestrant combination was well tolerated, with no new safety signals observed—including no cases of photopsia. While overall survival data remain immature, a clear positive trend was noted in both the ITT and ESR1-mutated groups.

If approved, giredestrant plus everolimus would become the first and only oral selective estrogen receptor degrader (SERD) combination available for patients in the post-CDK inhibitor setting.

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