Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial
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...
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| Veröffentlicht in: | Nature medicine 2024-09, Vol.30 (9), p.2568-2575 |
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| creator | Shi, Yuankai Guo, Wei Wang, Wei Wu, Yunteng Fang, Meiyu Huang, Xiaoming Han, Ping Zhang, Qingyuan Dong, Pin Zhou, Xiaohong Peng, Hanwei Hu, Chunhong Chen, Xiaopin Zhang, Shurong Chang, Zhiwei Li, Xiaojiang Ding, Yuhai Qu, Song Jing, Shanghua Zhang, Songnan Gui, Lin Sun, Yan Wang, Lin Liu, Yanyan Wu, Hui Li, Guoqing Fu, Zhichao Shi, Jianhua Jiang, Hao Bai, Yuansong Cui, Jiuwei Zheng, Yulong Cui, Wei Jia, Xiaojing Zhai, Limin Cai, Qingqing Xiong, Deming Wu, Yunong Cao, Junning Wu, Rong Hu, Guangyuan Peng, Liang Xie, Liangzhi Gai, Wenlin Wang, Yan Su, Yuehua |
| description | 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. |
| doi_str_mv | 10.1038/s41591-024-03110-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3073654683</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3105557788</sourcerecordid><originalsourceid>FETCH-LOGICAL-c326t-2da206d0ba7314c40f7959294855ed297f9fce03707418ba0a7f05d3b01b43d43</originalsourceid><addsrcrecordid>eNp9kUGP1SAUhYnROOPoH3BhSNy4qV4KFHBnJo6aTOJGE3eEwq3ts4Un0Jjx14u-URMXriDwnXNvziHkMYPnDLh-UQSThnXQiw44Y9CpO-ScSTF0TMGnu-0OSnfayOGMPCjlAAAcpLlPzrg2ojeGn5PD1RJTTXFdNjfSb0udqZ9xS3XG7I43dIk0o99zxlhpynTD6kp1dfF0Rheoi4FG9F-od9Fjfkkdze0tbct3DPQ4u4KU05oXtz4k9ya3Fnx0e16Qj1evP1y-7a7fv3l3-eq687wfatcH18MQYHSKM-EFTMpI0xuhpcTQGzWZySNwBUowPTpwagIZ-AhsFDwIfkGenXyPOX3dsVS7LcXjurqIaS-Wg-JDS0nzhj79Bz2kPce2neUMpJRKad2o_kT5nErJONljbnHlG8vA_mzCnpqwrQn7qwmrmujJrfU-bhj-SH5H3wB-Akr7ip8x_539H9sfzYGTMw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3105557788</pqid></control><display><type>article</type><title>Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial</title><source>MEDLINE</source><source>Nature Journals Online</source><source>SpringerLink Journals - AutoHoldings</source><creator>Shi, Yuankai ; Guo, Wei ; Wang, Wei ; Wu, Yunteng ; Fang, Meiyu ; Huang, Xiaoming ; Han, Ping ; Zhang, Qingyuan ; Dong, Pin ; Zhou, Xiaohong ; Peng, Hanwei ; Hu, Chunhong ; Chen, Xiaopin ; Zhang, Shurong ; Chang, Zhiwei ; Li, Xiaojiang ; Ding, Yuhai ; Qu, Song ; Jing, Shanghua ; Zhang, Songnan ; Gui, Lin ; Sun, Yan ; Wang, Lin ; Liu, Yanyan ; Wu, Hui ; Li, Guoqing ; Fu, Zhichao ; Shi, Jianhua ; Jiang, Hao ; Bai, Yuansong ; Cui, Jiuwei ; Zheng, Yulong ; Cui, Wei ; Jia, Xiaojing ; Zhai, Limin ; Cai, Qingqing ; Xiong, Deming ; Wu, Yunong ; Cao, Junning ; Wu, Rong ; Hu, Guangyuan ; Peng, Liang ; Xie, Liangzhi ; Gai, Wenlin ; Wang, Yan ; Su, Yuehua</creator><creatorcontrib>Shi, Yuankai ; Guo, Wei ; Wang, Wei ; Wu, Yunteng ; Fang, Meiyu ; Huang, Xiaoming ; Han, Ping ; Zhang, Qingyuan ; Dong, Pin ; Zhou, Xiaohong ; Peng, Hanwei ; Hu, Chunhong ; Chen, Xiaopin ; Zhang, Shurong ; Chang, Zhiwei ; Li, Xiaojiang ; Ding, Yuhai ; Qu, Song ; Jing, Shanghua ; Zhang, Songnan ; Gui, Lin ; Sun, Yan ; Wang, Lin ; Liu, Yanyan ; Wu, Hui ; Li, Guoqing ; Fu, Zhichao ; Shi, Jianhua ; Jiang, Hao ; Bai, Yuansong ; Cui, Jiuwei ; Zheng, Yulong ; Cui, Wei ; Jia, Xiaojing ; Zhai, Limin ; Cai, Qingqing ; Xiong, Deming ; Wu, Yunong ; Cao, Junning ; Wu, Rong ; Hu, Guangyuan ; Peng, Liang ; Xie, Liangzhi ; Gai, Wenlin ; Wang, Yan ; Su, Yuehua</creatorcontrib><description>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.</description><identifier>ISSN: 1078-8956</identifier><identifier>ISSN: 1546-170X</identifier><identifier>EISSN: 1546-170X</identifier><identifier>DOI: 10.1038/s41591-024-03110-7</identifier><identifier>PMID: 38942993</identifier><language>eng</language><publisher>New York: Nature Publishing Group US</publisher><subject>5-Fluorouracil ; 631/250/251 ; 631/67/1536 ; Adult ; Aged ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - adverse effects ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Apoptosis ; Biomedical and Life Sciences ; Biomedicine ; Cancer ; Cancer Research ; Cell death ; Chemotherapy ; Cisplatin ; Cisplatin - administration & dosage ; Cisplatin - therapeutic use ; Double-Blind Method ; Effectiveness ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - therapeutic use ; Head & neck cancer ; Head and neck carcinoma ; Head and Neck Neoplasms - drug therapy ; Head and Neck Neoplasms - pathology ; Humans ; Immunotherapy ; Infectious Diseases ; Male ; Metabolic Diseases ; Metastases ; Metastasis ; Middle Aged ; Molecular Medicine ; Monoclonal antibodies ; Neoplasm Metastasis ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - pathology ; Neurosciences ; PD-1 protein ; Placebos ; Safety ; Squamous cell carcinoma ; Squamous Cell Carcinoma of Head and Neck - drug therapy ; Squamous Cell Carcinoma of Head and Neck - pathology ; Survival</subject><ispartof>Nature medicine, 2024-09, Vol.30 (9), p.2568-2575</ispartof><rights>The Author(s), under exclusive licence to Springer Nature America, Inc. 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Springer Nature America, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-2da206d0ba7314c40f7959294855ed297f9fce03707418ba0a7f05d3b01b43d43</cites><orcidid>0000-0001-5447-3282 ; 0000-0003-4504-7622</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41591-024-03110-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41591-024-03110-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38942993$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shi, Yuankai</creatorcontrib><creatorcontrib>Guo, Wei</creatorcontrib><creatorcontrib>Wang, Wei</creatorcontrib><creatorcontrib>Wu, Yunteng</creatorcontrib><creatorcontrib>Fang, Meiyu</creatorcontrib><creatorcontrib>Huang, Xiaoming</creatorcontrib><creatorcontrib>Han, Ping</creatorcontrib><creatorcontrib>Zhang, Qingyuan</creatorcontrib><creatorcontrib>Dong, Pin</creatorcontrib><creatorcontrib>Zhou, Xiaohong</creatorcontrib><creatorcontrib>Peng, Hanwei</creatorcontrib><creatorcontrib>Hu, Chunhong</creatorcontrib><creatorcontrib>Chen, Xiaopin</creatorcontrib><creatorcontrib>Zhang, Shurong</creatorcontrib><creatorcontrib>Chang, Zhiwei</creatorcontrib><creatorcontrib>Li, Xiaojiang</creatorcontrib><creatorcontrib>Ding, Yuhai</creatorcontrib><creatorcontrib>Qu, Song</creatorcontrib><creatorcontrib>Jing, Shanghua</creatorcontrib><creatorcontrib>Zhang, Songnan</creatorcontrib><creatorcontrib>Gui, Lin</creatorcontrib><creatorcontrib>Sun, Yan</creatorcontrib><creatorcontrib>Wang, Lin</creatorcontrib><creatorcontrib>Liu, Yanyan</creatorcontrib><creatorcontrib>Wu, Hui</creatorcontrib><creatorcontrib>Li, Guoqing</creatorcontrib><creatorcontrib>Fu, Zhichao</creatorcontrib><creatorcontrib>Shi, Jianhua</creatorcontrib><creatorcontrib>Jiang, Hao</creatorcontrib><creatorcontrib>Bai, Yuansong</creatorcontrib><creatorcontrib>Cui, Jiuwei</creatorcontrib><creatorcontrib>Zheng, Yulong</creatorcontrib><creatorcontrib>Cui, Wei</creatorcontrib><creatorcontrib>Jia, Xiaojing</creatorcontrib><creatorcontrib>Zhai, Limin</creatorcontrib><creatorcontrib>Cai, Qingqing</creatorcontrib><creatorcontrib>Xiong, Deming</creatorcontrib><creatorcontrib>Wu, Yunong</creatorcontrib><creatorcontrib>Cao, Junning</creatorcontrib><creatorcontrib>Wu, Rong</creatorcontrib><creatorcontrib>Hu, Guangyuan</creatorcontrib><creatorcontrib>Peng, Liang</creatorcontrib><creatorcontrib>Xie, Liangzhi</creatorcontrib><creatorcontrib>Gai, Wenlin</creatorcontrib><creatorcontrib>Wang, Yan</creatorcontrib><creatorcontrib>Su, Yuehua</creatorcontrib><title>Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial</title><title>Nature medicine</title><addtitle>Nat Med</addtitle><addtitle>Nat Med</addtitle><description>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.</description><subject>5-Fluorouracil</subject><subject>631/250/251</subject><subject>631/67/1536</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Apoptosis</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Cell death</subject><subject>Chemotherapy</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Effectiveness</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - therapeutic use</subject><subject>Head & neck cancer</subject><subject>Head and neck carcinoma</subject><subject>Head and Neck Neoplasms - drug therapy</subject><subject>Head and Neck Neoplasms - pathology</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Infectious Diseases</subject><subject>Male</subject><subject>Metabolic Diseases</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Monoclonal antibodies</subject><subject>Neoplasm Metastasis</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - pathology</subject><subject>Neurosciences</subject><subject>PD-1 protein</subject><subject>Placebos</subject><subject>Safety</subject><subject>Squamous cell carcinoma</subject><subject>Squamous Cell Carcinoma of Head and Neck - drug therapy</subject><subject>Squamous Cell Carcinoma of Head and Neck - pathology</subject><subject>Survival</subject><issn>1078-8956</issn><issn>1546-170X</issn><issn>1546-170X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUGP1SAUhYnROOPoH3BhSNy4qV4KFHBnJo6aTOJGE3eEwq3ts4Un0Jjx14u-URMXriDwnXNvziHkMYPnDLh-UQSThnXQiw44Y9CpO-ScSTF0TMGnu-0OSnfayOGMPCjlAAAcpLlPzrg2ojeGn5PD1RJTTXFdNjfSb0udqZ9xS3XG7I43dIk0o99zxlhpynTD6kp1dfF0Rheoi4FG9F-od9Fjfkkdze0tbct3DPQ4u4KU05oXtz4k9ya3Fnx0e16Qj1evP1y-7a7fv3l3-eq687wfatcH18MQYHSKM-EFTMpI0xuhpcTQGzWZySNwBUowPTpwagIZ-AhsFDwIfkGenXyPOX3dsVS7LcXjurqIaS-Wg-JDS0nzhj79Bz2kPce2neUMpJRKad2o_kT5nErJONljbnHlG8vA_mzCnpqwrQn7qwmrmujJrfU-bhj-SH5H3wB-Akr7ip8x_539H9sfzYGTMw</recordid><startdate>202409</startdate><enddate>202409</enddate><creator>Shi, Yuankai</creator><creator>Guo, Wei</creator><creator>Wang, Wei</creator><creator>Wu, Yunteng</creator><creator>Fang, Meiyu</creator><creator>Huang, Xiaoming</creator><creator>Han, Ping</creator><creator>Zhang, Qingyuan</creator><creator>Dong, Pin</creator><creator>Zhou, Xiaohong</creator><creator>Peng, Hanwei</creator><creator>Hu, Chunhong</creator><creator>Chen, Xiaopin</creator><creator>Zhang, Shurong</creator><creator>Chang, Zhiwei</creator><creator>Li, Xiaojiang</creator><creator>Ding, Yuhai</creator><creator>Qu, Song</creator><creator>Jing, Shanghua</creator><creator>Zhang, Songnan</creator><creator>Gui, Lin</creator><creator>Sun, Yan</creator><creator>Wang, Lin</creator><creator>Liu, Yanyan</creator><creator>Wu, Hui</creator><creator>Li, Guoqing</creator><creator>Fu, Zhichao</creator><creator>Shi, Jianhua</creator><creator>Jiang, Hao</creator><creator>Bai, Yuansong</creator><creator>Cui, Jiuwei</creator><creator>Zheng, Yulong</creator><creator>Cui, Wei</creator><creator>Jia, Xiaojing</creator><creator>Zhai, Limin</creator><creator>Cai, Qingqing</creator><creator>Xiong, Deming</creator><creator>Wu, Yunong</creator><creator>Cao, Junning</creator><creator>Wu, Rong</creator><creator>Hu, Guangyuan</creator><creator>Peng, Liang</creator><creator>Xie, Liangzhi</creator><creator>Gai, Wenlin</creator><creator>Wang, Yan</creator><creator>Su, Yuehua</creator><general>Nature Publishing Group US</general><general>Nature Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QG</scope><scope>7QL</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>7TO</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5447-3282</orcidid><orcidid>https://orcid.org/0000-0003-4504-7622</orcidid></search><sort><creationdate>202409</creationdate><title>Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial</title><author>Shi, Yuankai ; Guo, Wei ; Wang, Wei ; Wu, Yunteng ; Fang, Meiyu ; Huang, Xiaoming ; Han, Ping ; Zhang, Qingyuan ; Dong, Pin ; Zhou, Xiaohong ; Peng, Hanwei ; Hu, Chunhong ; Chen, Xiaopin ; Zhang, Shurong ; Chang, Zhiwei ; Li, Xiaojiang ; Ding, Yuhai ; Qu, Song ; Jing, Shanghua ; Zhang, Songnan ; Gui, Lin ; Sun, Yan ; Wang, Lin ; Liu, Yanyan ; Wu, Hui ; Li, Guoqing ; Fu, Zhichao ; Shi, Jianhua ; Jiang, Hao ; Bai, Yuansong ; Cui, Jiuwei ; Zheng, Yulong ; Cui, Wei ; Jia, Xiaojing ; Zhai, Limin ; Cai, Qingqing ; Xiong, Deming ; Wu, Yunong ; Cao, Junning ; Wu, Rong ; Hu, Guangyuan ; Peng, Liang ; Xie, Liangzhi ; Gai, Wenlin ; Wang, Yan ; Su, Yuehua</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-2da206d0ba7314c40f7959294855ed297f9fce03707418ba0a7f05d3b01b43d43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>5-Fluorouracil</topic><topic>631/250/251</topic><topic>631/67/1536</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Apoptosis</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Cell death</topic><topic>Chemotherapy</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Effectiveness</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - therapeutic use</topic><topic>Head & neck cancer</topic><topic>Head and neck carcinoma</topic><topic>Head and Neck Neoplasms - drug therapy</topic><topic>Head and Neck Neoplasms - pathology</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Infectious Diseases</topic><topic>Male</topic><topic>Metabolic Diseases</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Middle Aged</topic><topic>Molecular Medicine</topic><topic>Monoclonal antibodies</topic><topic>Neoplasm Metastasis</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neoplasm Recurrence, Local - pathology</topic><topic>Neurosciences</topic><topic>PD-1 protein</topic><topic>Placebos</topic><topic>Safety</topic><topic>Squamous cell carcinoma</topic><topic>Squamous Cell Carcinoma of Head and Neck - drug therapy</topic><topic>Squamous Cell Carcinoma of Head and Neck - pathology</topic><topic>Survival</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shi, Yuankai</creatorcontrib><creatorcontrib>Guo, Wei</creatorcontrib><creatorcontrib>Wang, Wei</creatorcontrib><creatorcontrib>Wu, Yunteng</creatorcontrib><creatorcontrib>Fang, Meiyu</creatorcontrib><creatorcontrib>Huang, Xiaoming</creatorcontrib><creatorcontrib>Han, Ping</creatorcontrib><creatorcontrib>Zhang, Qingyuan</creatorcontrib><creatorcontrib>Dong, Pin</creatorcontrib><creatorcontrib>Zhou, Xiaohong</creatorcontrib><creatorcontrib>Peng, Hanwei</creatorcontrib><creatorcontrib>Hu, Chunhong</creatorcontrib><creatorcontrib>Chen, Xiaopin</creatorcontrib><creatorcontrib>Zhang, Shurong</creatorcontrib><creatorcontrib>Chang, Zhiwei</creatorcontrib><creatorcontrib>Li, Xiaojiang</creatorcontrib><creatorcontrib>Ding, Yuhai</creatorcontrib><creatorcontrib>Qu, Song</creatorcontrib><creatorcontrib>Jing, Shanghua</creatorcontrib><creatorcontrib>Zhang, Songnan</creatorcontrib><creatorcontrib>Gui, Lin</creatorcontrib><creatorcontrib>Sun, Yan</creatorcontrib><creatorcontrib>Wang, Lin</creatorcontrib><creatorcontrib>Liu, Yanyan</creatorcontrib><creatorcontrib>Wu, Hui</creatorcontrib><creatorcontrib>Li, Guoqing</creatorcontrib><creatorcontrib>Fu, Zhichao</creatorcontrib><creatorcontrib>Shi, Jianhua</creatorcontrib><creatorcontrib>Jiang, Hao</creatorcontrib><creatorcontrib>Bai, Yuansong</creatorcontrib><creatorcontrib>Cui, Jiuwei</creatorcontrib><creatorcontrib>Zheng, Yulong</creatorcontrib><creatorcontrib>Cui, Wei</creatorcontrib><creatorcontrib>Jia, Xiaojing</creatorcontrib><creatorcontrib>Zhai, Limin</creatorcontrib><creatorcontrib>Cai, Qingqing</creatorcontrib><creatorcontrib>Xiong, Deming</creatorcontrib><creatorcontrib>Wu, Yunong</creatorcontrib><creatorcontrib>Cao, Junning</creatorcontrib><creatorcontrib>Wu, Rong</creatorcontrib><creatorcontrib>Hu, Guangyuan</creatorcontrib><creatorcontrib>Peng, Liang</creatorcontrib><creatorcontrib>Xie, Liangzhi</creatorcontrib><creatorcontrib>Gai, Wenlin</creatorcontrib><creatorcontrib>Wang, Yan</creatorcontrib><creatorcontrib>Su, Yuehua</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Nature medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shi, Yuankai</au><au>Guo, Wei</au><au>Wang, Wei</au><au>Wu, Yunteng</au><au>Fang, Meiyu</au><au>Huang, Xiaoming</au><au>Han, Ping</au><au>Zhang, Qingyuan</au><au>Dong, Pin</au><au>Zhou, Xiaohong</au><au>Peng, Hanwei</au><au>Hu, Chunhong</au><au>Chen, Xiaopin</au><au>Zhang, Shurong</au><au>Chang, Zhiwei</au><au>Li, Xiaojiang</au><au>Ding, Yuhai</au><au>Qu, Song</au><au>Jing, Shanghua</au><au>Zhang, Songnan</au><au>Gui, Lin</au><au>Sun, Yan</au><au>Wang, Lin</au><au>Liu, Yanyan</au><au>Wu, Hui</au><au>Li, Guoqing</au><au>Fu, Zhichao</au><au>Shi, Jianhua</au><au>Jiang, Hao</au><au>Bai, Yuansong</au><au>Cui, Jiuwei</au><au>Zheng, Yulong</au><au>Cui, Wei</au><au>Jia, Xiaojing</au><au>Zhai, Limin</au><au>Cai, Qingqing</au><au>Xiong, Deming</au><au>Wu, Yunong</au><au>Cao, Junning</au><au>Wu, Rong</au><au>Hu, Guangyuan</au><au>Peng, Liang</au><au>Xie, Liangzhi</au><au>Gai, Wenlin</au><au>Wang, Yan</au><au>Su, Yuehua</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial</atitle><jtitle>Nature medicine</jtitle><stitle>Nat Med</stitle><addtitle>Nat Med</addtitle><date>2024-09</date><risdate>2024</risdate><volume>30</volume><issue>9</issue><spage>2568</spage><epage>2575</epage><pages>2568-2575</pages><issn>1078-8956</issn><issn>1546-170X</issn><eissn>1546-170X</eissn><abstract>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.</abstract><cop>New York</cop><pub>Nature Publishing Group US</pub><pmid>38942993</pmid><doi>10.1038/s41591-024-03110-7</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-5447-3282</orcidid><orcidid>https://orcid.org/0000-0003-4504-7622</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1078-8956 |
| ispartof | Nature medicine, 2024-09, Vol.30 (9), p.2568-2575 |
| issn | 1078-8956 1546-170X 1546-170X |
| language | eng |
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| source | MEDLINE; Nature Journals Online; SpringerLink Journals - AutoHoldings |
| subjects | 5-Fluorouracil 631/250/251 631/67/1536 Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Apoptosis Biomedical and Life Sciences Biomedicine Cancer Cancer Research Cell death Chemotherapy Cisplatin Cisplatin - administration & dosage Cisplatin - therapeutic use Double-Blind Method Effectiveness Female Fluorouracil - administration & dosage Fluorouracil - therapeutic use Head & neck cancer Head and neck carcinoma Head and Neck Neoplasms - drug therapy Head and Neck Neoplasms - pathology Humans Immunotherapy Infectious Diseases Male Metabolic Diseases Metastases Metastasis Middle Aged Molecular Medicine Monoclonal antibodies Neoplasm Metastasis Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - pathology Neurosciences PD-1 protein Placebos Safety Squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck - drug therapy Squamous Cell Carcinoma of Head and Neck - pathology Survival |
| title | Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial |
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