医药行业研报：吉利德SG联合K药一线治疗PD-L1+ TNBC达到PFS主要终点

太平洋证券股份...2025-05-30

事件：近日，吉利德宣布III 期ASCENT-04 研究达到了PFS 主要终点。（来源：吉利德，太平洋证券研究院）核心观点：SG（TROP2 ADC）联合K 药一线治疗PD-L1+ TNBC 头对头击败K 药+化疗，PFS 延长具有统计学和临床意义。ASCENT-04/KEYNOTED19是一项全球多中心、开放标签、随机III 期临床试验，入组了443 例未经治疗的不可手术局部晚期或转移性TNBC...

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万女性。PD-L1 阳性（CPS≥10）mTNBC的一线标准治疗为帕博利珠单抗联合化疗，中位PFS 为9.7 个月，mOS为23 个月。SG 联合帕博利珠单抗显著较化疗联合帕博利珠单抗，显著改善患者的PFS，若最终OS 数据积极，该组合有望成为一线治疗TNBC（PD-L1+）的新标准。此外，SG 对比化疗在一线治疗 PD-L1 阴性TNBC的3 期临床ASCENT-03 也达到了PFS 主要终点。SG 联合化疗辅助治疗术后和新辅助治疗后仍有残留浸润性疾病TNBC 的ASCENT-05 研究正在积极推进。一线PD-L1 阴性TNBC 市场竞争激烈，主要竞品包括Dato、SKB264、BL-B01D1。SG 已获批用于后线TNBC 及后线HR+/HER2-两项适应症，2024 年销售金额13 亿美金，同比增长24%。基于ASCENT-03/04/05 研究，SG 覆盖人群有望大幅提升。另一方面，PDL1 阴性TNBC 市场面临激烈竞争。第一三共Dato（TROP2 ADC）一线治疗PD-L1 阴性mTNBC的TROPION-Breast02 研究预计2025H1 数据读出，默沙东/科伦博泰已启动SKB264（TROP2 ADC）辅助治疗TNBC 和一线治疗PD-L1 阴性TNBC的两项全球3 期临床，BMS/百利天恒启动了BL-B01D1（EGFR/HER3ADC）一线治疗PD-L1 阴性TNBC 的全球2/3 期临床。风险提示：新药研发及上市不及预期；市场竞争加剧风险等。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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