PD-(L)1+ADC：PD-(L)1 单抗+国产TROP2、HER2 ADC 有望迭代肿瘤一线疗法 PD-L1 ADC 提供免疫耐药新选择

山西证券2025-07-28

PD-(L)1 单抗+ADC 有望成为多种肿瘤一线标准疗法。PD-(L)1 单抗阻断PD-1 与配体PD-L1 作用，激活T 细胞发挥抗肿瘤功效。PD-(L)1 单抗是肿瘤免疫(IO)基石药物，单药或联合化疗是多个肿瘤一线标准疗法。IO+ADC有望提升ORR 、克服耐药，迭代肿瘤一线标准疗法， PD-1 单抗Keytruda+Nectin-4 ADC Padcev 一线治疗la/mUC 已被...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20250728112621a6c51762&s=b><strong>山西证券</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>PD-(L)1 单抗+ADC 有望成为多种肿瘤一线标准疗法。PD-(L)1 单抗阻断PD-1 与配体PD-L1 作用，激活T 细胞发挥抗肿瘤功效。PD-(L)1 单抗是肿瘤免疫(IO)基石药物，单药或联合化疗是多个肿瘤一线标准疗法。IO+ADC有望提升ORR 、克服耐药， 迭代肿瘤一线标准疗法， PD-1 单抗Keytruda+Nectin-4 ADC Padcev 一线治疗la/mUC 已被...</p>\n\n<a 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ADCsac-TMT+PD-L1 单抗塔戈利单抗治疗ORR 为59.3%，mPFS 为15.0 个月(化疗+PD-1 的mPFS 为9~10 个月)。一线驱动基因阴性NSCLC 中（n=96），截至2024 年4 月，两药组（Dato-DXd+Keytruda）和Dato-DXd+Keytruda+化疗的cORR 为54.8%和55.6%，mPFS 为11.2 个月和6.8 个月。一线TNBC(PD-L1≥10%)中，2025 年5 月，Keytruda+Trodelvy 的mPFS 为11.2 个月，PFS HR为0.65，26%OS HR 为0.89（vs Keytruda+化疗）。TNBC 对照组mPFS 仍低于Keynote-355 试验中PD-L1≥10%表达者Keytruda 联合化疗的9.7 个月。PD-1 单抗+HER2 ADC 在HER2 高表达胃癌II/III 期临床PFS 优于标准疗法。在HER2 高表达胃癌中，维迪西妥单抗联合特瑞普利单抗及化疗和维迪西妥联合特瑞普利单抗+曲妥珠单抗相比特瑞普利单抗+曲妥珠单抗+CAPOX 化疗疗效显著，ORR 为66.7%vs82.4%vs68.8%；mPFS 未达到vs未达到vs14.1 个月，PFS HR 为0.46 和0.59；12 个月PFS 率为66.3%，67%和53.6%。PD-L1 ADC 在后线NSCLC I 期临床抗肿瘤疗效显著。PD-L1 ADCHLX43 兼具毒素精准杀伤和肿瘤免疫作用，既往中位3 线NSCLC 中，HLX43治疗后ORR 为38.5%，中位PFS 为5.4 个月，mOS 未达到。其中sqNSCLC（n=15）和非鳞状非小细胞肺癌nsqNSCLC（n=6）的ORR 分别为40%和33.3%，DCR 为73.3%和100%，脑转移NSCLC 患者DCR 为100%。风险提示：PD-(L)1 联合ADC 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