Roche's new breast cancer drug Phase III trial meets primary endpoint, extending progression-free survival in advanced patients

According to the Zhitong Finance APP, Swiss pharmaceutical company Roche (RHHBY.US) announced that the Phase III evERA study of Giredestrant for the treatment of breast cancer has achieved positive results. Giredestrant helped patients with a specific type of advanced breast cancer extend their progression-free survival. Whether the drug can extend patients' lives (i.e., the overall survival target) remains to be seen, but Roche noted in a statement on Monday that there is a "significant positive trend." These results are part of a series of drug trial data that Roche plans to announce this year, which will determine Roche's competitiveness in the future. Last week, Roche agreed to acquire biopharmaceutical company 89bio Inc. for up to $3.5 billion to strengthen its product pipeline in the burgeoning obesity and related disease treatment market. The results showed that the study met its primary endpoint, with both the ITT population and the ESR1 mutation subgroup achieving statistically and clinically significant improvements in progression-free survival (PFS) after treatment with Giredestrant in combination with everolimus. Overall survival (OS) data has not matured yet but shows a significant positive trend. Follow-up will continue for systematic analysis. Giredestrant is a next-generation oral selective estrogen receptor degrader (SERD) and full antagonist independently developed by Roche, designed to prevent estrogen from binding to estrogen receptors (ER) and induce their degradation, thereby inhibiting or slowing the growth of cancer cells. The evERA study of breast cancer is a randomized, open-label, multicenter clinical trial that evaluates the efficacy and safety of Giredestrant in combination with everolimus compared to physician's choice of endocrine therapy in combination with everolimus in ER-positive and HER2-negative (ER+/HER2-) patients with locally advanced or metastatic breast cancer who have received CDK4/6 inhibitors and endocrine therapy in the adjuvant or locally advanced/metastatic setting. The primary endpoint of the study is progression-free survival (PFS) in the investigator-assessed intent-to-treat (ITT) population and the ESR1 mutation subgroup. The trial has been expanded to include patients with ESR1 mutations above the natural prevalence to assess the efficacy in this population (up to 40% of ER+ patients treated with CDK inhibitors carry ESR1 mutations)