可以多活8.2个月！国产双抗挑战全球肿瘤“药王”总生存期胜出

第一财经09-15

2026年世界肺癌大会，对于国产创新药而言，不只是“被看见”，更要回答一个硬核的问题：到底能不能让患者活得更久。　　继翰森制药ADC药物刷新全球小细胞肺癌二线治疗最长总生存期（OS）纪录外，另外一款国产创新药挑战全球肿瘤“药王”总生存期的数据也揭晓了。　　单挑全球肿瘤“药王”　　9月15日，康方生物（09926.HK）PD-1/VEGF双抗依沃西，对比帕博利珠单抗（即K药）一线治疗PD-L1表达...

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Domestic bispecific antibodies challenge the global cancer \"king\" to win overall survival","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"FHLC":0.6,"HRTS":0.6,"TRUH":0.6,"FTXH":0.6,"RXL":0.6,"XLV":0.6,"JDOC":0.6,"IXJ":0.6,"IHE":0.6,"IYH":0.6,"PPH":0.6,"MRK":1.91,"VHT":0.6,"GDOC":0.6,"PAWZ":0.6,"KURE":0.6,"09926":1.98,"BMED":0.6},"content_text":"2026年世界肺癌大会，对于国产创新药而言，不只是“被看见”，更要回答一个硬核的问题：到底能不能让患者活得更久。　　继翰森制药ADC药物刷新全球小细胞肺癌二线治疗最长总生存期（OS）纪录外，另外一款国产创新药挑战全球肿瘤“药王”总生存期的数据也揭晓了。　　单挑全球肿瘤“药王”　　9月15日，康方生物（09926.HK）PD-1/VEGF双抗依沃西，对比帕博利珠单抗（即K药）一线治疗PD-L1表达阳性(PD-L1 TPS≥1%)的局部晚期或转移性非小细胞肺癌（NSCLC）的随机、双盲、对照、多中心、注册性III期临床研究数据在大会上公布。　　研究结果显示：在意向治疗人群中，相较K药，依沃西可以使患者中位OS（一半人活过这个时长）延长8.2个月，达到30.8个月。　　具体到PD-L1 TPS≥50%人群（也是K药疗效表现最强人群）中，依沃西组中位OS还未达到，而K药组的中位OS为23.2个月，这意味着依沃西在PD-L1高表达人群上可以展现出更强的总生存获益优势。　　依沃西是全球首个“头对头”单药挑战K药成功的药物。2024年全球畅销的药物排名中，K药位列第一位，全球销售额达到294.82亿美元，这款药物的研发厂家是跨国药企默沙东。虽然K药在2025年不再是全球“药王”，但至今仍然是全球肿瘤领域销售额最高的药物，2025年全球销售额达到316.8亿美元。　　长期以来，以K药为代表的PD-1单抗引领实体瘤免疫治疗时代的发展。K药的“封王”之路，实际上也离不开其在治疗PD-L1阳性人群一线非小细胞肺癌上的突出疗效，这不仅奠定了这款药在肿瘤免疫治疗领域的行业地位，也奠定了免疫治疗在整个肿瘤治疗中的地位。　　这次数据揭晓之前，康方生物创始人、董事长夏瑜在9月13日举行的电话交流会上表示，依沃西的这项III期临床研究是在2022年底启动的。“当时做这个决定其实是站在肿瘤免疫治疗前辈的肩膀上：既然这个领域十几年做得这么好，我们是不是还能做得更好？基于这个基础，我们大胆地做了单药对单药的头对头研究设计。K药的KN-042研究在TPS≥1%的人群获批上市，我们也选择从PD-L1TPS>1%这个人群去对比K药——这本身就是个更大胆的决定。”　　夏瑜表示，这是这么多年来，第一次有产品能与免疫治疗的开山鼻祖帕博利珠单抗做单药头对头，且在不联合其他药物的前提下，在随机双盲对照研究中做出这样的强阳性数据。　　能否成为新一代免疫治疗基石药物　　作为肿瘤免疫的核心靶点，PD-（L）1因其广谱抗肿瘤作用及持久抗肿瘤作用奠定了在免疫治疗领域的基石地位，但也由于免疫微环境的复杂性及耐药性，整个PD-（L）1仍无法完全满足临床需求。众多药企正在比拼开发新一代免疫基石疗法。　　相比K药这样的PD-1单抗，依沃西属于PD-1/VEGF双抗，核心价值在于“一药双靶”，同时发挥免疫效应和抗血管生成效应（理论上比K药多一个靶点，且可以发挥2个靶点的协同作用）。　　依沃西与K药之间的对决，不仅关系到两款药物之间疗效比拼，更关系到PD-1/VEGF双抗能否真正成为新一代免疫治疗基石药物。当前，全球有众多药企在PD-1/VEGF双抗赛道上也进行了押注。　　夏瑜亦认为，经过36个月的随访，依沃西很好地延长了生存获益，且没有新的安全性信号暴露，这再次验证，依沃西不是简单的“两个药联合使用”，它有自己独特的分子作用机制。随着依沃西开发的不断推进，以及同行在PD-1/VEGF双抗上的共同努力，肿瘤免疫治疗已经上了一个新的台阶。　　不过，康方生物当前披露的数据是在中国人群中开展的研究，依沃西能否真正撼动K药的地位，还差临门一脚，即有待国际多中心数据出炉。　　康方生物方面亦表示，目前，依沃西单药对比帕博利珠单抗一线治疗PD-L1高表达非小细胞肺癌的国际多中心III期临床研究（HARMONi-7/AK112-3007）正在高效开展。（文章来源：第一财经）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"2","news_tag":"","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; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.50.0","shortVersion":"4.50.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2667648612","isCrawlerRequest":true}