选择性雌激素受体降解剂(SERD)

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罗氏(RHHBY.US)乳腺癌新药三期试验达主要终点 延长晚期患者无进展生存期
Zhi Tong Cai Jing· 2025-09-22 09:39
Core Insights - Roche's Giredestrant has achieved positive results in the Phase III evERA study for breast cancer, extending progression-free survival (PFS) for patients with specific types of advanced breast cancer [1][2] - The total survival data remains immature but shows a "clear positive trend," indicating potential for future efficacy [1] - Roche's acquisition of 89bio Inc. for up to $3.5 billion aims to enhance its product pipeline in the growing obesity and related disease treatment market [1] Group 1 - Giredestrant is a next-generation oral selective estrogen receptor degrader (SERD) designed to inhibit estrogen binding to estrogen receptors, thereby slowing cancer cell growth [2] - The evERA study is a randomized, open-label, multi-center clinical trial assessing the efficacy and safety of Giredestrant combined with Everolimus compared to physician's choice of endocrine therapy plus Everolimus in ER+/HER2- advanced or metastatic breast cancer patients [2] - The primary endpoint of the study is progression-free survival (PFS) in the intention-to-treat (ITT) population and the ESR1 mutation subgroup, with a focus on patients who have previously received CDK4/6 inhibitors [2]