K+EV显著改善MIBC辅助治疗EFS和OS

华创新药2025-12-17

PADCEV®联合Keytruda®显著提高肌层浸润性膀胱癌患者生存率，无论顺铂适用性--对于符合条件的肌层浸润性膀胱癌患者，PADCEV联合Keytruda是首个且唯一在手术前后使用、无需含铂化疗即可改善无事件生存期和总生存期的方案--EV-304研究的积极数据，加上近期EV-303试验前所未有的结果，突显了该联合方案有潜力在膀胱癌更早阶段成为新的无铂标准治疗选择--EV-304 III期试验...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251217221245a6ae610e&s=b><strong>华创新药</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>PADCEV®联合Keytruda®显著提高肌层浸润性膀胱癌患者生存率，无论顺铂适用性--对于符合条件的肌层浸润性膀胱癌患者，PADCEV联合Keytruda是首个且唯一在手术前后使用、无需含铂化疗即可改善无事件生存期和总生存期的方案--EV-304研究的积极数据，加上近期EV-303试验前所未有的结果，突显了该联合方案有潜力在膀胱癌更早阶段成为新的无铂标准治疗选择--EV-304 III期试验...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251217221245a6ae610e&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0306806265.USD","symbol_name":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" 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MIBC","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1.91},"content_text":"PADCEV®联合Keytruda®显著提高肌层浸润性膀胱癌患者生存率，无论顺铂适用性--对于符合条件的肌层浸润性膀胱癌患者，PADCEV联合Keytruda是首个且唯一在手术前后使用、无需含铂化疗即可改善无事件生存期和总生存期的方案--EV-304研究的积极数据，加上近期EV-303试验前所未有的结果，突显了该联合方案有潜力在膀胱癌更早阶段成为新的无铂标准治疗选择--EV-304 III期试验结果将在即将举行的医学会议上公布，并与全球卫生监管部门讨论潜在的上市申请事宜东京和纽约，2025年12月17日 – 安斯泰来制药集团（东京证券交易所：4503，总裁兼首席执行官：冈村直树，\"安斯泰来\"）和辉瑞公司（纽约证券交易所：PFE）今日宣布，针对PADCEV®（enfortumab vedotin，一种靶向Nectin-4的抗体药物偶联物）联合Keytruda®（pembrolizumab，一种PD-1抑制剂）的III期EV-304临床试验（亦称为KEYNOTE-B15）期中分析获得了积极的顶线结果。这项关键性研究正在评估该联合方案作为新辅助及辅助治疗（手术前后）对比标准新辅助化疗（吉西他滨和顺铂），用于适合顺铂化疗的肌层浸润性膀胱癌患者。该试验达到了其主要终点，在无事件生存期以及关键次要终点总生存期方面显示出具有临床意义和统计学显著性的改善。试验也达到了另一个次要终点——PADCEV联合pembrolizumab新辅助治疗对比新辅助化疗的病理学完全缓解率，并观察到了具有临床意义和统计学显著性的改善。PADCEV联合pembrolizumab的安全性特征与该治疗方案已知的安全性特征一致。杜克癌症研究所膀胱癌项目及癌症免疫治疗中心主任、EV-304主要研究者 Christopher Hoimes, DO 表示：\"尽管现有治疗方案，仍有近一半的肌层浸润性膀胱癌患者在诊断后三年内进展为转移性疾病。EV-304的结果代表了尿路上皮癌治疗新时代的一个关键里程碑。EV-303和EV-304的结果共同表明，恩福单抗联合帕博利珠单抗的围手术期治疗方案能够对肌层浸润性膀胱癌患者的治疗历程产生积极影响，无论患者是否适合顺铂治疗，均能提供显著的生存获益，这预示着从传统含铂化疗的转变以及改变标准治疗模式的潜力。\"安斯泰来肿瘤开发负责人 Moitreyee Chatterjee-Kishore, PhD, MBA 表示：\"基于近期在美国获批用于不适合顺铂治疗的MIBC患者，这些积极的EV-304研究结果进一步证实了PADCEV联合pembrolizumab有潜力改善更广泛的肌层浸润性膀胱癌患者的生存结局。结合EV-303的数据，这些结果强化了证据，支持该联合方案成为无论顺铂适用性如何的患者的一个治疗选择。我们致力于带来亟需的治疗进展，并为更多患者带来希望。\"辉瑞首席肿瘤学官 Jeff Legos, PhD, MBA 表示：\"肌层浸润性膀胱癌患者首次在围手术期环境下，无需含铂化疗，就从联合疗法中看到了显著的生存获益，这预示着该患者群体可能迎来新的标准治疗。EV-304的结果，加上近期EV-303试验前所未有的结果，展示了该方案作为无论顺铂适用性如何的膀胱癌治疗基石的未来前景。\"膀胱癌是全球第九大常见癌症，全球每年有超过614,000名患者被诊断，其中美国估计有85,000人。MIBC约占所有膀胱癌病例的30%。对于符合条件的MIBC患者，标准治疗是顺铂为基础的新辅助化疗，随后进行手术。然而，即使接受手术，仍有一半的MIBC患者会出现疾病复发。PADCEV联合pembrolizumab目前尚未获批用于适合顺铂治疗的MIBC患者的新辅助和辅助治疗。这些结果将提交至即将举行的医学大会进行展示，并将与全球卫生监管部门讨论潜在的上市申请事宜。基于III期EV-303临床试验（亦称为KEYNOTE-905）的结果，PADCEV联合pembrolizumab或pembrolizumab联合透明质酸酶-α, pmah方案近期已获得美国食品药品监督管理局批准，用于不适合顺铂治疗的MIBC患者，作为新辅助治疗，并在膀胱切除术后继续作为辅助治疗。+++关于EV-304/ KEYNOTE-B15试验EV-304试验是一项正在进行的、开放标签、随机、对照的III期研究，旨在评估PADCEV联合pembrolizumab作为新辅助及辅助治疗对比新辅助化疗（吉西他滨和顺铂）用于适合顺铂化疗的MIBC患者。患者被随机分配接受PADCEV联合pembrolizumab的新辅助及辅助（手术前后）治疗（A组）或新辅助化疗（B组）。所有患者均接受以治愈为目的的手术（膀胱切除术），并在完成术前全身治疗后被随机分配至任一治疗组。该试验的主要终点是无事件生存期，定义为从随机化到发生以下任何事件首次出现的时间：疾病进展导致无法进行根治性膀胱切除术，或残留病灶患者未能接受RC，手术时肉眼可见残留病灶，基于盲态独立中心审查确定的局部或远处复发，或任何原因导致的死亡。关键的次要终点包括总生存期和病理学完全缓解率。有关全球EV-304试验的更多信息，请访问clinicaltrials.gov。关于PADCEV® (enfortumab vedotin)PADCEV® (enfortumab vedotin) 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