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Stephen V Liu, MD· @StephenVLiu · X·· 2026-04-19Score60

adebrelimab

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肺癌 — 围手术期 IO、KRAS NSCLC

围手术期 IO 已经是 MNC 主战场。中国 PD-L1 抗体(adebrelimab)用 EFS 数据挤进同一张桌子。下一步不是再报一个缓解率,而是停药能不能由 MRD 决定、双抗能不能在新辅助里超过单抗。

Deep dive

对可手术的Ⅱ至ⅢB期非小细胞肺癌(NSCLC),手术联合(新)辅助全身治疗虽是标准方案,转移性复发仍常见且与不良生存相关[1],而Ⅲ期疾病异质性强,新辅助治疗加手术与根治性放化疗孰优孰劣曾长期难分高下[3]。新辅助纳武利尤单抗联合化疗的Ⅲ期研究把中位无事件生存(EFS)从20.8个月提高到31.6个月(HR 0.63),病理完全缓解率达24.0%[2],后续总生存分析进一步显示死亡风险下降(HR 0.72;5年总生存率65.4%对55.0%)[4],由此确立围手术期免疫治疗地位。但IASLC共识同时提醒,Ⅱ、Ⅲ期可切除NSCLC仍有大量知识空白待解[5],且已发表的关键Ⅲ期证据来自抗PD-1单抗纳武利尤单抗[2][4],疗效预测标志物尚在探索。

新消息来自2026年4月17—22日在圣迭戈举行的AACR年会[7]:一项Ⅲ期研究显示,在可切除Ⅱ、Ⅲ期NSCLC的围手术期治疗中加入抗PD-L1抗体adebrelimab联合化疗带来获益;据报道,该方案显著改善了EFS与主要病理缓解(MPR),安全性可控[8]。这一Ⅲ期并非凭空而来:adebrelimab(SHR-1316)联合白蛋白紫杉醇与卡铂的围手术期方案此前已在Ⅰb期接受评估[9],并在可切除Ⅱ—Ⅲ期NSCLC中报告了较高的MPR率[10]。消息还强调,ctDNA清除作为预测疗效的潜在生物标志物重要性持续上升;所谓ctDNA清除率,即治疗后血浆中循环肿瘤DNA转为检测不到的患者比例[11]。

放回上述脉络,本次数据的推进有二。其一,此前确立围手术期免疫治疗格局的Ⅲ期证据均基于抗PD-1药物[2][4],这条消息把“免疫检查点抑制剂联合化疗”的获益延伸到抗PD-L1通路的adebrelimab;其二,该药已有围手术期经验背书——在食管鳞癌新辅助Ⅰb期研究中达到安全性与可行性主要终点,pCR率8%,2年总生存率92%[6]——如今在NSCLC获得Ⅲ期支持。相较之下,靶向治疗在早期NSCLC仅有辅助奥希替尼获批、尚无获批的新辅助靶向药[1],而ctDNA清除若获验证,有望为疗效预测提供一种动态监测工具。

当然,消息本身未披露具体疗效数字,也未提及总生存结果;“潜在标志物”的措辞本身就提示ctDNA清除的检测标准与临床决策价值尚未确立,正如IASLC专家组所言,不少关键问题仍需数年才能有确切答案[5]。

Body · original

#AACR26 Perioperative adebrelimab (vs placebo) improved MPR (53.8% vs 18.4%) and pCR rates (31.1% vs 7.6%) with an OS trend (HR 0.57). ctDNA dynamics predictive of MPR, pCR, and EFS as well.

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Conference abstracts
CT014NCT04316364matched by 药名 adebrelimab
Perioperative adebrelimab (A) plus chemotherapy (chemo) in resectable stage II-III NSCLC: Phase 3 EFS interim analysis (IA) and molecular residual disease (MRD) analysis

Yi-Long Wu, Wen-Zhao Zhong, Li-Xu Yan, Keneng Chen, Wanpu Yan, Yongzhong Luo, Wenxiang Wang, Wenqun Xing, Xiaolong Yan, Lin Wu, Feng Yao, Dongsheng Yue, Naiquan Mao, Yu Qi, Bentong Yu, Jianji Guo, Jindan Kai, Yuejun Chen, Hui Wang, Qin Zhang, Lunxu Liu, Honghai Wang, Yuanyuan Ji, Yongtao Han, Yongxiang Song, Jianjun Xu, Wei Guo, Hongxu Liu, Di Ge, Hecheng Li, XiuJuan Qu, Jifang Yao, Junfeng Liu, Tingyan Zhong, Yanhua Huang, Li Song, Wei Shi

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CT038NCT05276609NCT06332170matched by 药名 adebrelimab
Combination of risvutatug rezetecan and adebrelimab in previously treated advanced nsq-NSCLC without actionable genomic alterations: Results from ARTEMIS-101, a phase 1 study

Hua Zhong, Haifeng Liu, Wei Zheng, Linlin Wang, Baogang Liu, Fangling Ning, Yongzhong Luo, Qiming Wang, Weiliang Zhu, Jianying Zhou, Qingwei Zhao, Ruoyu Wang, Xiang Li, Juan Li, Runbo Zhong, Yizhou Jin, Xiangru Mao, Jing Wang, Qingyuan Liu, Xiaoqing Zhang

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CT301NCT05482568matched by 药名 adebrelimab
SHR-A1811 ± adebrelimab as first-line (1L) treatment for advanced HER2-mutant NSCLC: A randomized phase 2 cohort from a phase 1b/2 study

Shun Lu, Zhengbo Song, Ziming Li, Haiyong Wang, Yan Yu, Qitao Yu, Shaozhang Zhou, Zhiyong He, Yan Wang, Yiping Zhang, Songyan Han, Rui Meng, Guoqun Zhang, Longhua Sun, Xueqin Chen, Yong Mao, Yongsheng Li, Yongzhong Luo, Kangsheng Gu, Xuhong Min, Bo Jin, Runxiang Yang, Yanqiu Zhao, Liqiang Zhong, Jun Wang, Zhiguo Zhou, Chengzhi Zhou, Kaijun Zhang, Xiaotong Li, Xinjing Ma, Liju Zong, You Li

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Source: Stephen V Liu, MD · x.com

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