Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors—A phase 1/1b study
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<sup>high</sup> & MYC<sup>low</sup> distinguishes NPCs with the most favorable PFS. In NSCLC, PD-L1<sup>+</sup>/TIL<sup>+</sup> 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).
Authors
- Hongyun Zhao (ORCID: https://orcid.org/0000-0002-1251-3888)
- Shilin Xue (ORCID: https://orcid.org/0000-0002-8056-7458)
- Qun Chen (ORCID: https://orcid.org/0009-0003-0791-0998)
- Wuyun Su
- Jinhui Xue (ORCID: https://orcid.org/0000-0002-9791-2940)
- Fan Luo (ORCID: https://orcid.org/0000-0002-6254-608X)
- Chuan Jin (ORCID: https://orcid.org/0000-0002-6119-4617)
- Yi Ba
- Ying Cheng (ORCID: https://orcid.org/0000-0001-9908-597X)
- Dong Zhu (ORCID: https://orcid.org/0000-0002-3241-2996)
- Xiaoyan Kang (ORCID: https://orcid.org/0009-0001-5947-0205)
- Changbin Zhu
- Aimin Zang (ORCID: https://orcid.org/0000-0001-6777-1959)
- Xianling Liu
- Xiangcai Wang (ORCID: https://orcid.org/0000-0002-7162-0552)
- Song Qu (ORCID: https://orcid.org/0000-0003-2784-6148)
- Zhendong Chen (ORCID: https://orcid.org/0009-0009-4632-7432)
- Yan Huang (ORCID: https://orcid.org/0000-0002-1789-5088)
- Qian Li (ORCID: https://orcid.org/0000-0003-1300-3377)
- Huijun Li (ORCID: https://orcid.org/0000-0002-2896-3867)
- Qingshan Li (ORCID: https://orcid.org/0000-0002-5564-0860)
- Chao Wang (ORCID: https://orcid.org/0000-0002-1625-6524)
- Li Zhang (ORCID: https://orcid.org/0000-0002-6672-4808)
- Zhan Huang (ORCID: https://orcid.org/0000-0002-4024-1592)
- Weiwei Li (ORCID: https://orcid.org/0000-0001-7432-3310)
- Yunpeng Yang (ORCID: https://orcid.org/0000-0002-4472-1251)
- Chuanben Chen (ORCID: https://orcid.org/0000-0002-2225-7865)
- Yiping Zhang (ORCID: https://orcid.org/0009-0004-8008-3199)
- Yuxiang Ma
- Jianbo He (ORCID: https://orcid.org/0000-0002-0623-9763)
- Shaoyan Lin
Institutions
- Fujian Medical University (CN)
- Central South University (CN)
- Sun Yat-sen University (CN)
- Guangxi Medical University (CN)
- Anhui Medical University (CN)
- Tianjin Medical University Cancer Institute and Hospital (CN)
- Jilin Province Tumor Hospital (CN)
- Zhejiang Cancer Hospital (CN)
- Chengde Medical University (CN)
- First Affiliated Hospital of Gannan Medical University (CN)
- Affiliated Hospital of Hebei University (CN)
- Sun Yat-sen University Cancer Center (CN)
- Fujian Provincial Cancer Hospital (CN)
- Second Affiliated Hospital of Anhui Medical University (CN)
- Dian Diagnostics (China) (CN)
- Second Xiangya Hospital of Central South University (CN)
- Guangzhou Medical University Cancer Hospital (CN)
- Qilu Hospital of Shandong University (CN)
- Shandong First Medical University (CN)
- Union Hospital (CN)
- University of Chinese Academy of Sciences (CN)
- Inner Mongolia Medical University (CN)
- Guangzhou Medical University (CN)
Publication Details
- Journal
- Cell Reports Medicine
- Published
- 2025-10-01
- DOI
- https://doi.org/10.1016/j.xcrm.2025.102396
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00