Swiss pharmaceutical company Roche Holding Ltd (RHHBY.US) announced positive results from the Phase III evERA study of Giredestrant for breast cancer treatment. Giredestrant helped extend disease progression-free survival in patients with specific types of advanced breast cancer. Whether the drug can extend patient life (overall survival endpoint) remains to be observed, but Roche noted in Monday's statement that there is a "clear positive trend." These results are part of a series of drug trial data that Roche plans to release this year, which will determine the company's future competitiveness. Last week, Roche agreed to acquire biopharmaceutical company 89bio Inc. for up to $3.5 billion to strengthen its pipeline in the booming obesity and related disease treatment market.
Results showed that the study met its primary endpoint, with both the ITT population and ESR1 mutation subgroup achieving statistically significant and clinically meaningful extension of PFS when treated with Giredestrant combined with everolimus. Overall survival (OS) data is not yet mature but shows a clear positive trend. Follow-up will continue for systematic analysis.
Giredestrant is a next-generation oral selective estrogen receptor degrader (SERD) and complete antagonist independently developed by Roche, designed to prevent estrogen from binding to estrogen receptors (ER), induce their degradation, and thereby prevent or slow cancer cell growth.
The evERA breast cancer study is a randomized, open-label, multicenter clinical trial that evaluated the efficacy and safety of Giredestrant combined with everolimus versus physician's choice of endocrine therapy combined with everolimus in treating locally advanced or metastatic breast cancer patients who are ER-positive and HER2-negative (ER+/HER2-) and have previously received CDK4/6 inhibitor and endocrine therapy treatment in adjuvant or locally advanced/metastatic settings.
The study's primary endpoint was investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) population and ESR1 mutation subgroup. The trial was enriched for ESR1 mutation patients above the natural prevalence rate to evaluate efficacy in this population (up to 40% of ER+ patients carry ESR1 mutations among those who have received CDK inhibitor treatment).