QL1706（一种双功能 PD-1/CTLA-4 双阻断剂）在晚期实体瘤中的更新疗效和预测性生物标志物——一项 1/1b 期研究

英文原题：Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study.

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Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study.

PubMed 2025/10/03（内容时间） Cell Rep Med Q1 · IF 14（JCR 2025）

非小细胞肺癌鼻咽癌宫颈癌地区：中国

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研究概要

在接受 QL1706（5 mg/kg）治疗的 468 例患者中，非小细胞肺癌（NSCLC）的中位无进展生存期（mPFS）和中位总生存期（mOS）分别为 1.5 个月和 14.2 个月，鼻咽癌（NPC）为 1.9 个月和 20.2 个月，以及 4.2 个月和 18.6 个月。

中文摘要

QL1706在I/Ib期研究中治疗实体瘤显示出有前景的疗效。本文报告更新后的长期生存结局和生物标志物分析。468例接受QL1706（5 mg/kg）治疗的患者中，非小细胞肺癌（NSCLC）患者的无进展生存期中位数（mPFS）和总生存期中位数（mOS）分别为1.5个月和14.2个月；鼻咽癌（NPC）患者分别为1.9个月和20.2个月；宫颈癌（CC）患者分别为4.2个月和18.6个月。肝转移与NSCLC患者较差的PFS和OS以及CC患者较差的OS相关；NPC患者乳酸脱氢酶升高与PFS和OS缩短相关。CDK4/11q13二倍体状态或GZMK高表达、MYC低表达可识别PFS最有利的NPC患者。在NSCLC中，PD-L1阳性/TIL阳性或ARG1:CXCL13比值较低提示结局较好。QL1706为实体瘤患者带来长期生存获益，所发现的分子标志物有助于筛选合适候选者。本研究注册于ClinicalTrials.gov（NCT04296994和NCT05171790）。

展开英文摘要原文

QL1706 has shown promising efficacy in solid tumors in a phase 1/1b study. Here, we report updated long-term survival outcomes and biomarker analyses. Among 468 patients treated with QL1706 (5 mg/kg), median progression-free survival (mPFS) and overall survival (mOS) are 1.5 and 14.2 months for non-small cell lung cancer (NSCLC), 1.9 and 20.2 months for nasopharyngeal carcinoma (NPC), and 4.2 and 18.6 months for cervical cancer (CC), respectively. Liver metastasis is correlated with poor progression-free survival (PFS) and overall survival (OS) in NSCLC and poor OS in CC, while elevated lactate dehydrogenase is linked to shorter PFS and OS in NPC. CDK4/11q13 diploid or the expression of GZMK high & MYC low distinguishes NPCs with the most favorable PFS. In NSCLC, PD-L1 + /TIL + or a low ARG1:CXCL13 ratio indicates better outcomes. QL1706 offers long-term survival benefits in solid tumors, with identified molecular markers aiding in selecting suitable candidates. This study has been registered on clinicaltrials.gov (NCT04296994 and NCT05171790).

论文信息

作者: Ma Y、Lin S、Chen Q、Xue J、Yang Y、Zang A、Cheng Y、Zhang Y
第一作者单位: Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, No. 651 Dongfeng East Road, Guangzhou 510060, China.China
通讯作者单位: Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, No. 651 Dongfeng East Road, Guangzhou 510060, China. Electronic address: zhaohy@sysucc.org.cn.China
文献类型: I 期临床试验
期刊: Cell reports. Medicine2025 Oct 21

原文标识: PubMed 41045933　·　DOI 10.1016/j.xcrm.2025.102396

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