Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial

被引：2

作者：

Shi, Yuankai ^{[1
]}

Guo, Wei ^{[2
]}

Wang, Wei ^{[3
]}

Wu, Yunteng ^{[2
]}

Fang, Meiyu ^{[4
]}

Huang, Xiaoming ^{[5
]}

Han, Ping ^{[5
]}

Zhang, Qingyuan ^{[6
]}

Dong, Pin ^{[7
]}

Zhou, Xiaohong ^{[8
]}

Peng, Hanwei ^{[9
]}

Hu, Chunhong ^{[10
]}

Chen, Xiaopin ^{[11
]}

Zhang, Shurong ^{[12
]}

Chang, Zhiwei ^{[13
]}

Li, Xiaojiang ^{[14
]}

Ding, Yuhai ^{[15
]}

Qu, Song ^{[16
]}

Jing, Shanghua ^{[17
]}

Zhang, Songnan ^{[18
]}

Gui, Lin ^{[1
]}

Sun, Yan ^{[19
]}

Wang, Lin ^{[20
]}

Liu, Yanyan ^{[21
]}

Wu, Hui ^{[21
]}

Li, Guoqing ^{[22
]}

Fu, Zhichao ^{[23
]}

Shi, Jianhua ^{[24
]}

Jiang, Hao ^{[25
]}

Bai, Yuansong ^{[26
]}

Cui, Jiuwei ^{[27
]}

Zheng, Yulong ^{[28
]}

Cui, Wei ^{[29
]}

Jia, Xiaojing ^{[30
]}

Zhai, Limin ^{[31
]}

Cai, Qingqing ^{[32
]}

Xiong, Deming ^{[33
]}

Wu, Yunong ^{[34
]}

Cao, Junning ^{[35
]}

Wu, Rong ^{[36
]}

Hu, Guangyuan ^{[37
]}

Peng, Liang ^{[38
]}

Xie, Liangzhi ^{[39
]}

Gai, Wenlin ^{[39
]}

Wang, Yan ^{[39
]}

Su, Yuehua ^{[39
]}

机构：

[1] Chinese Acad Med Sci & Peking Union Med Coll, Beijing Key Lab Clin Study Anticanc Mol Targeted D, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp,Dept Med Oncol, Beijing 100021, Peoples R China

[2] Shanghai Jiao Tong Univ, Dept Oral & Maxillofacial Head & Neck Oncol, Shanghai Peoples Hosp 9, Sch Med,Coll Stomatol,Natl Clin Res Ctr Oral Dis,S, Shanghai, Peoples R China

[3] Hunan Canc Hosp, Changsha, Peoples R China

[4] Zhejiang Canc Hosp, Hangzhou, Peoples R China

[5] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Guangzhou, Peoples R China

[6] Harbin Med Univ, Canc Hosp, Harbin, Peoples R China

[7] Shanghai Gen Hosp, Shanghai, Peoples R China

[8] Chongqing Univ, Canc Hosp, Chongqing, Peoples R China

[9] Shantou Univ, Canc Hosp, Med Coll, Shantou, Peoples R China

[10] Cent South Univ, Xiangya Hosp 2, Changsha, Peoples R China

[11] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China

[12] Capital Med Univ, Beijing Tongren Hosp, Beijing, Peoples R China

[13] Zhengzhou Univ, Affiliated Hosp 1, Dept Oncol, Zhengzhou, Peoples R China

[14] Yunnan Canc Hosp, Kunming, Peoples R China

[15] Ganzhou Peoples Hosp, Ganzhou, Peoples R China

[16] Guangxi Med Univ, Canc Hosp, Nanning, Peoples R China

[17] Hebei Med Univ, Hosp 4, Shijiazhuang, Peoples R China

[18] Yanbian Univ Hosp, Yanji, Peoples R China

[19] Peking Univ, Canc Hosp, Beijing, Peoples R China

[20] Hainan Gen Hosp, Haikou, Peoples R China

[21] Henan Canc Hosp, Zhengzhou, Peoples R China

[22] Jiangxi Canc Hosp, Nanchang, Peoples R China

[23] Joint Logist Support Force PLA, Hosp 900, Fuzhou, Peoples R China

[24] LinYi Canc Hosp, Linyi, Peoples R China

[25] Bengbu Med Univ, Affiliated Hosp 1, Dept Radiat Oncol, Bengbu, Peoples R China

[26] Jilin Univ, Bethune Hosp 3, Changchun, Peoples R China

[27] First Hosp Jilin Univ, Changchun, Jilin, Peoples R China

[28] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Hangzhou, Peoples R China

[29] Jining Med Univ, Affiliated Hosp, Jining, Peoples R China

[30] Jilin Univ, Norman Bethune Hosp 2, Changchun, Peoples R China

[31] Shandong First Med Univ, Affiliated Canc Hosp, Jinan, Peoples R China

[32] Sun Yat Sen Univ, Canc Ctr, Guangzhou, Peoples R China

[33] Chongqing Univ, Three Gorges Hosp, Chongqing, Peoples R China

[34] Nanjing Med Univ, Stomatol Coll, Nanjing, Peoples R China

[35] Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China

[36] China Med Univ, Shengjing Hosp, Shenyang, Peoples R China

[37] HUST, Tongji Med Coll, Wuhan, Peoples R China

[38] Chinese Peoples Liberat Army Gen Hosp, Beijing, Peoples R China

[39] Sinocelltech Ltd, Beijing Engn Res Ctr Prot & Antibody, Beijing, Peoples R China

来源：

NATURE MEDICINE | 2024年 / 30卷 / 09期

关键词：

SQUAMOUS-CELL CARCINOMA; 1ST-LINE TREATMENT; PLUS CETUXIMAB; PEMBROLIZUMAB; TRENDS;

D O I：

10.1038/s41591-024-03110-7

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

Immunotherapy combined with chemotherapy regimen has been shown to be effective in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). However, due to the small number of patients, its efficacy remains controversial in Asian populations, particularly in mainland China. Here a randomized, double-blind phase 3 trial evaluated the efficacy and safety of finotonlimab (SCT-I10A), a programmed cell death 1 (PD-1) monoclonal antibody, combined with cisplatin plus 5-fluorouracil (C5F) for the first-line treatment of R/M HNSCC. Eligible patients (n = 370) were randomly 2:1 assigned to receive finotonlimab plus C5F (n = 247) or placebo plus C5F (n = 123). The primary endpoint was overall survival (OS). In the finotonlimab plus C5F group, OS was 14.1 months (95% confidence interval (CI) 11.1-16.4), compared with 10.5 months (95% CI 8.1-11.8) in the placebo plus C5F group. The hazard ratio was 0.73 (95% CI 0.57-0.95, P = 0.0165), meeting the predefined superiority criteria for the primary endpoint. Finotonlimab plus C5F showed significant OS superiority compared with C5F alone and acceptable safety profile with R/M HNSCC, supporting its use as a first-line treatment option for R/M HNSCC. These results validate the efficacy and safety of the combination of finotonlimab and C5F in Asian patients with R/M HNSCC. ClinicalTrials.gov identifier: NCT04146402. In this phase 3 trial, first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with anti-PD-1 finotonlimab plus cisplatin plus 5-fluorouracil (C5F) prolonged overall survival compared with placebo plus C5F.

引用

页码：2568 / 2575

页数：20

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