PD-1(L1)／VEGF双抗：多项NSCLCIII期临床达到PFS终点结直肠癌等肿瘤一线临床获益明显

山西证券2025-07-10

药物点评：PD-1(L1)/VEGF 双抗是潜在肿瘤免疫基石药物。PD-1（L1）/VEGF 双抗对抗血管和免疫检查点协同抑制，增强肿瘤组织滞留能力和疗效，可治疗多种肿瘤。首款PD-1/VEGF 双抗康方生物-依沃西单抗在EGFR-TKI 经治非鳞状NSCLC、一线PD-L1 阳性NSCLC 中国上市，在NSCLC 等超6 种一线癌症III 期临床。PD-L1/VEGF 双抗百时美施贵宝-...

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PFS HR=0.51，39%OS HR=0.777（vsPD-1 单抗）。一线鳞状NSCLC III 期临床，依沃西联合化疗达到PFS 终点（vsPD-1 单抗）；II 期临床，联合组在鳞状NSCLC ORR 为71.4%，DCR为90.5%，mDOR 为12.7 个月，mPFS 为11.1 个月，9 个月OS 率为90.4%；II 期临床，联合组在非鳞状NSCLC ORR 为54.2%，DCR 为95.8%，mDOR为15.4 个月，mPFS 为13.3 个月，9 个月OS 率为81.9%。经治EGFR 突变NSCLC，依沃西联合化疗PFS HR 为0.52，OS HR 为0.79（vs 化疗）。依沃西在结直肠癌、头颈鳞癌、胆道癌一线II 期临床获益明显。一线MSS 结直肠癌，依沃西+FOLFOXIRI 组ORR 为81.8%，9 个月PFS 为81.4%。依沃西+莱法利单抗+FOLFOXIRI 组ORR 为88.2%，DCR 为100%，9 个月PFS 率为86.2%。一线头颈鳞癌（N=30），依沃西单药ORR 为30%，DCR为80%，mPFS 为5.0 个月；联合莱法利ORR 为60%，DCR 为90%，mPFS为7.1 个月。一线胆道癌，依沃西联合化疗ORR 为63.6%，DCR 为100%，mPFS 为8.5 个月，mOS 为16.8 个月。PM8002 在一线TNBC Ib/II 期、二线SCLC II 期临床生存获益突出，707 在NSCLC、结直肠癌II 期临床ORR 获益明显。一线TNBC（N=42），PM8002 联合白紫ORR 为78.6%，DCR 为95.2%，mPFS 为14.0 个月。二线SCLC（N=70），PM8002 联合紫杉醇mPFS 为5.5 个月，mOS 为14.3 个月。一线PD-L1 阳性NSCLC，707 单药（N=83）ORR 为70.8%，DCR 为100.0%；联用化疗（N=108）在非鳞NSCLC ORR 为58.3%，DCR 为100%，在鳞状NSCLC ORR 为81.3%，DCR 为100%。RASm 或BRAFm non-MSI-H/pMMR结直肠癌，707 单药≥三线（N=7）治疗ORR 为33.3%，707 组合疗法一线（N=63）治疗ORR 为36.3%。风险提示：对外授权不及预期或合作破裂风险，海外临床推进不及预期风险，总生存期（OS）无法证明显著优势带来的海外上市失败风险等。","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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; 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PD-1(L1)／VEGF双抗：多项NSCLCIII期临床达到PFS终点 结直肠癌等肿瘤一线临床获益明显

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PD-1(L1)／VEGF双抗：多项NSCLCIII期临床达到PFS终点结直肠癌等肿瘤一线临床获益明显