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达尔西利联合内分泌辅助治疗HR+/HER2-BCIII期临床研究设计
达尔西利联合内分泌辅助治疗HR+/HER2-BCIII期临床研究设计
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所属报告:
恒瑞医药-公司研究报告-开启新产品周期国际化创新启航-230314(71页).pdf
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中国HER+/HER2低表达BC治疗标准:HER2ADC治疗地位持续上升中
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行业数据
2025-10-23
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美国HER+/HER2低表达BC治疗标准:HER2ADC治疗地位持续上升中
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2025-10-23
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维迪西妥单抗联合免疫奠定在HER2表达mUC患者晚期一线治疗的标准治疗地位(非头对头)
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行业数据
2025-10-23
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图表12KN026(HER2双抗)药物机理
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行业数据
2025-09-26
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图表8Crinetics专业知识驱动内分泌治疗从发现到商业化的全流程演进
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行业数据
2025-09-25
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中国药企HER2双抗ADC研发进度领先全球
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行业数据
2025-09-24
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中国药企HER2双抗ADC研发进度领先全球
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行业数据
2025-09-24
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JSKN003治疗HER2阳性(IHC3+)实体瘤临床结果表现出良好的耐受性、安全性和抗肿瘤活性
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行业数据
2025-09-23
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国内已获批上市的HER2单抗(截至2025年7月)
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行业数据
2025-09-23
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JSKN003治疗HER2阳性(IHC3+)实体瘤临床结果表现出良好的耐受性、安全性和抗肿瘤活性
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行业数据
2025-09-22
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HER2抗国内竞争格局
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竞争格局
2025-08-13
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TQB2102在HER2低表达乳腺癌的疗效(Ph1b)
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行业数据
2025-08-01
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全球HER2双抗ADC临床研发布局(截至2025年6月)
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2025-08-01
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ZG006:二线及以上晚期神经内分泌癌中单药显示良好的有效性和安全性
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行业数据
2025-07-15
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DAWNA-1 研究提供了更贴近中国患者诊疗现状的、安全性更高的证据。入组患者中绝经前(围绝经期)患者占 44%,更符合中国年轻患者更多的流行病学特征;研究治疗组 27%的患者在既往解救治疗中接受过化疗。这是因为中国晚期HR+/HER2-乳腺癌患者的治疗仍以化疗为主,一线化疗占比 78.2%,二线化疗占比 55.1%,而欧洲一线 CDK4/6 抑制剂的使用率则高达 87%。DAWNA-1 研究结果显示,达尔西利联合氟维司群 治疗可以延长 9.4 个月的中位无进展生存期(mPFS,16.6 个月 vs 7.2 个月),患者疾病进展或死亡风险降低了 50%,且肝脏毒性更低,实验组 3 级及以上转氨酶升高发生率仅有 0.4%,在同类药品的临床研究中发生率最低。此外,DAWNA-2 研究达尔西利联合芳香化酶抑制剂(AI:来曲唑或阿那曲唑)一线治疗 HR+/HER2-晚期乳腺癌于近期达到主要研究终点,共纳入 456 例中国患者,按 2:1 随机分配至达尔西利+AI 组或安慰剂+AI 组,独立数据监察委员会(IDMC)判定主要终点的中期分析结果达到方案预设的优效标准。2022 ESMO展示了 DAWNA-2 中期分析结果,达尔西利组中研究者评估的中位 PFS 为 30.6 个月,较安慰剂组显著延长 12.4 个月,疾病进展或死亡风险降低 49%。
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恒瑞医药-公司研究报告-开启新产品周期国际化创新启航-230314(71页).pdf
、HER-2ADC结构设计对比
MONARCHE研究设计及结论
哌柏西利、阿贝西利、利柏西利和达尔西利治疗晚期乳腺癌疗效对比分析
表6、CDK4/6抑制剂国内样本医院销售额(百万元)202020212022哌柏西利13.1824.469.65
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