Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial
Abstract A randomized double-blind phase 3 trial (CHOICE-01, NCT03856411) demonstrated that combining toripalimab with chemotherapy substantially improves progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients without pretreatment. This study presents the prespecifie...
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Nature Publishing Group
2024-12-01
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| Series: | Signal Transduction and Targeted Therapy |
| Online Access: | https://doi.org/10.1038/s41392-024-02087-6 |
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| author | Jia Zhong Kailun Fei Lin Wu Baolan Li Zhijie Wang Ying Cheng Xiaoling Li Xicheng Wang Liang Han Xiaohong Wu Yun Fan Yan Yu Dongqing Lv Jianhua Shi Jianjin Huang Shaozhang Zhou Baohui Han Guogui Sun Qisen Guo Youxin Ji Xiaoli Zhu Sheng Hu Wei Zhang Qiming Wang Yuming Jia Ziping Wang Yong Song Jingxun Wu Meiqi Shi Xingya Li Zhigang Han Yunpeng Liu Zhuang Yu An-Wen Liu Xiuwen Wang Caicun Zhou Diansheng Zhong Liyun Miao Zhihong Zhang Hui Zhao Jun Yang Dong Wang Yingyi Wang Qiang Li Xiaodong Zhang Mei Ji Zhenzhou Yang Jiuwei Cui Beili Gao Buhai Wang Hu Liu Lei Nie Mei He Shi Jin Wei Gu Yongqian Shu Tong Zhou Jian Feng Xinmei Yang Cheng Huang Bo Zhu Yu Yao Sheng Yao Jianjun Yu Shang li Cai Yiran Cai Jiachen Xu Wei Zhuang Xianmin Luo Jianchun Duan Jie Wang |
| author_facet | Jia Zhong Kailun Fei Lin Wu Baolan Li Zhijie Wang Ying Cheng Xiaoling Li Xicheng Wang Liang Han Xiaohong Wu Yun Fan Yan Yu Dongqing Lv Jianhua Shi Jianjin Huang Shaozhang Zhou Baohui Han Guogui Sun Qisen Guo Youxin Ji Xiaoli Zhu Sheng Hu Wei Zhang Qiming Wang Yuming Jia Ziping Wang Yong Song Jingxun Wu Meiqi Shi Xingya Li Zhigang Han Yunpeng Liu Zhuang Yu An-Wen Liu Xiuwen Wang Caicun Zhou Diansheng Zhong Liyun Miao Zhihong Zhang Hui Zhao Jun Yang Dong Wang Yingyi Wang Qiang Li Xiaodong Zhang Mei Ji Zhenzhou Yang Jiuwei Cui Beili Gao Buhai Wang Hu Liu Lei Nie Mei He Shi Jin Wei Gu Yongqian Shu Tong Zhou Jian Feng Xinmei Yang Cheng Huang Bo Zhu Yu Yao Sheng Yao Jianjun Yu Shang li Cai Yiran Cai Jiachen Xu Wei Zhuang Xianmin Luo Jianchun Duan Jie Wang |
| author_sort | Jia Zhong |
| collection | DOAJ |
| description | Abstract A randomized double-blind phase 3 trial (CHOICE-01, NCT03856411) demonstrated that combining toripalimab with chemotherapy substantially improves progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients without pretreatment. This study presents the prespecified final analysis of overall survival (OS) and biomarkers utilizing circulating tumor DNA (ctDNA) and tissue-based sequencing. Additionally, the analysis revealed a higher median overall survival (OS, 23.8 months) in the toripalimab group than that in the control group (17.0 months). (HR = 0.69, 95%CI: 0.57–0.93, nominal P = 0.01). This survival benefit was particularly notable in the non-squamous subgroup. As the first phase 3 study to perform both baseline tissue whole-exome sequencing (WES) and peripheral blood ctDNA testing, we investigated efficacy predictive biomarkers based on both tissue and ctDNA, Genomic sequencing of ctDNA showed high concordance with tumor tissue independently confirmed that individuals exhibiting a high tumor mutational burden, as well as mutations in the FA-PI3K-Akt and IL-7 signaling pathways benefited more from the toripalimab treatment. Furthermore, a ctDNA response observed on cycle 3 day 1, was associated with improved clinical outcomes for patients treated with the combination therapy. In conclusion, Toripalimab plus chemotherapy yields significant improvements in OS as a first-line treatment. The study highlights the utility of ctDNA as a proxy for tumor tissue, providing novel prospects for predicting efficacy of immuno-chemotherapy through continuous ctDNA monitoring. |
| format | Article |
| id | doaj-art-747b3f5c798e4dbabe8cd689c9985909 |
| institution | DOAJ |
| issn | 2059-3635 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Nature Publishing Group |
| record_format | Article |
| series | Signal Transduction and Targeted Therapy |
| spelling | doaj-art-747b3f5c798e4dbabe8cd689c99859092025-08-20T02:39:38ZengNature Publishing GroupSignal Transduction and Targeted Therapy2059-36352024-12-01911910.1038/s41392-024-02087-6Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trialJia Zhong0Kailun Fei1Lin Wu2Baolan Li3Zhijie Wang4Ying Cheng5Xiaoling Li6Xicheng Wang7Liang Han8Xiaohong Wu9Yun Fan10Yan Yu11Dongqing Lv12Jianhua Shi13Jianjin Huang14Shaozhang Zhou15Baohui Han16Guogui Sun17Qisen Guo18Youxin Ji19Xiaoli Zhu20Sheng Hu21Wei Zhang22Qiming Wang23Yuming Jia24Ziping Wang25Yong Song26Jingxun Wu27Meiqi Shi28Xingya Li29Zhigang Han30Yunpeng Liu31Zhuang Yu32An-Wen Liu33Xiuwen Wang34Caicun Zhou35Diansheng Zhong36Liyun Miao37Zhihong Zhang38Hui Zhao39Jun Yang40Dong Wang41Yingyi Wang42Qiang Li43Xiaodong Zhang44Mei Ji45Zhenzhou Yang46Jiuwei Cui47Beili Gao48Buhai Wang49Hu Liu50Lei Nie51Mei He52Shi Jin53Wei Gu54Yongqian Shu55Tong Zhou56Jian Feng57Xinmei Yang58Cheng Huang59Bo Zhu60Yu Yao61Sheng Yao62Jianjun Yu63Shang li Cai64Yiran Cai65Jiachen Xu66Wei Zhuang67Xianmin Luo68Jianchun Duan69Jie Wang70State Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeHunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityBeijing Chest Hospital, Capital Medical UniversityState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeJilin Cancer HospitalLiaoning Cancer Hospital & InstituteThe First Affiliated Hospital, School of Clinical Medicine of Guangdong Pharmaceutical UniversityXuzhou Central HospitalJiangnan University Affiliated HospitalCancer Hospital of the University of Chinese Academy of SciencesHarbin Medical University Cancer HospitalTaizhou Hospital of Zhejiang ProvinceLinyi Cancer HospitalThe Second Affiliated Hospital of Zhejiang University School of MedicineGuangxi Medical University Affiliated Tumor HospitalShanghai Chest HospitalTangshan People’s HospitalShangdong Cancer HospitalQingdao Central HospitalZhongda Hospital Southeast UniversityHubei Cancer HospitalThe First Affiliated Hospital of Nanchang UniversityHenan Cancer HospitalThe Second People’s Hospital of YibinPeking University Cancer HospitalJinling Hospital, Nanjing University School of MedicineThe First Affiliated Hospital of Xiamen UniversityJiangsu Cancer HospitalThe First Affiliated Hospital of Zhengzhou UniversityAffiliated Tumor Hospital of Xinjiang Medical UniversityThe First Hospital of China Medical UniversityThe Affiliated Hospital of Qingdao UniversityThe Second Affiliated Hospital of Nanchang UniversityQilu Hospital of Shandong UniversityShanghai Pulmonary HospitalTianjin Medical University General HospitalAffiliated Drum Tower Hospital, Medical School of Nanjing UniversityAnhui Provincial Cancer HospitalThe Second Hospital of Anhui Medical UniversityThe Second Affiliated Hospital of Guangzhou Medical UniversityArmy Medical Center of PLA, Daping HospitalPeking Union Medical College HospitalShanghai East Hospital of Tongji UniversityNantong Tumor HospitalThe First People’s Hospital of ChangzhouThe Second Affiliated Hospital of Chongqing UniversityThe First Hospital of Jilin UniversityRuijin Hospital Shanghai Jiaotong University, School of MedicineSubei People’s Hospital of Jiangsu ProvinceAnhui Provincial Cancer HospitalShaanxi Provincial Cancer HospitalShanxi Provincial People’s HospitalCancer Hospital of Chinese Academy of Medical Sciences, Shenzhen CenterNanjing First HospitalThe First Affiliated Hospital of Nanjing Medical UniversityChangZhou Cancer HospitalAffiliated Hospital of Nantong UniversityJiaxing No. 1 HospitalFujian Cancer HospitalXinqiao Hospital of Army Medical UniversityFirst Affiliated Hospital of Xi’an Jiaotong UniversityTopAlliance BiosciencesTopAlliance BiosciencesBurning Rock BiotechBurning Rock BiotechState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeShanghai Junshi BiosciencesState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeState Key Laboratory of Molecular Oncology, CAMS Key Laboratory of Translational Research on Lung Cancer, Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeAbstract A randomized double-blind phase 3 trial (CHOICE-01, NCT03856411) demonstrated that combining toripalimab with chemotherapy substantially improves progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients without pretreatment. This study presents the prespecified final analysis of overall survival (OS) and biomarkers utilizing circulating tumor DNA (ctDNA) and tissue-based sequencing. Additionally, the analysis revealed a higher median overall survival (OS, 23.8 months) in the toripalimab group than that in the control group (17.0 months). (HR = 0.69, 95%CI: 0.57–0.93, nominal P = 0.01). This survival benefit was particularly notable in the non-squamous subgroup. As the first phase 3 study to perform both baseline tissue whole-exome sequencing (WES) and peripheral blood ctDNA testing, we investigated efficacy predictive biomarkers based on both tissue and ctDNA, Genomic sequencing of ctDNA showed high concordance with tumor tissue independently confirmed that individuals exhibiting a high tumor mutational burden, as well as mutations in the FA-PI3K-Akt and IL-7 signaling pathways benefited more from the toripalimab treatment. Furthermore, a ctDNA response observed on cycle 3 day 1, was associated with improved clinical outcomes for patients treated with the combination therapy. In conclusion, Toripalimab plus chemotherapy yields significant improvements in OS as a first-line treatment. The study highlights the utility of ctDNA as a proxy for tumor tissue, providing novel prospects for predicting efficacy of immuno-chemotherapy through continuous ctDNA monitoring.https://doi.org/10.1038/s41392-024-02087-6 |
| spellingShingle | Jia Zhong Kailun Fei Lin Wu Baolan Li Zhijie Wang Ying Cheng Xiaoling Li Xicheng Wang Liang Han Xiaohong Wu Yun Fan Yan Yu Dongqing Lv Jianhua Shi Jianjin Huang Shaozhang Zhou Baohui Han Guogui Sun Qisen Guo Youxin Ji Xiaoli Zhu Sheng Hu Wei Zhang Qiming Wang Yuming Jia Ziping Wang Yong Song Jingxun Wu Meiqi Shi Xingya Li Zhigang Han Yunpeng Liu Zhuang Yu An-Wen Liu Xiuwen Wang Caicun Zhou Diansheng Zhong Liyun Miao Zhihong Zhang Hui Zhao Jun Yang Dong Wang Yingyi Wang Qiang Li Xiaodong Zhang Mei Ji Zhenzhou Yang Jiuwei Cui Beili Gao Buhai Wang Hu Liu Lei Nie Mei He Shi Jin Wei Gu Yongqian Shu Tong Zhou Jian Feng Xinmei Yang Cheng Huang Bo Zhu Yu Yao Sheng Yao Jianjun Yu Shang li Cai Yiran Cai Jiachen Xu Wei Zhuang Xianmin Luo Jianchun Duan Jie Wang Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial Signal Transduction and Targeted Therapy |
| title | Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial |
| title_full | Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial |
| title_fullStr | Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial |
| title_full_unstemmed | Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial |
| title_short | Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial |
| title_sort | toripalimab plus chemotherapy for first line treatment of advanced non small cell lung cancer choice 01 final os and biomarker exploration of a randomized double blind phase 3 trial |
| url | https://doi.org/10.1038/s41392-024-02087-6 |
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