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進行性腎臓細胞癌 (ETER100) の第一線ベンメルストーバルトとアノチニブ対スニチニブ:多センター,ランダム化,オープンラベル,第3相試験

Aiping Zhou ¹, Pengfei Shen ², Juan Li ³

¹Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
²Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu, China.
³Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
⁴Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
⁵Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
⁶Department of Urologic Oncology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
⁷Department of Urology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine of Central South University, Changsha, China.
⁸Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.
⁹Department of Urology, Cancer Hospital of Dalian University of Technology, Liaoning Cancer Hospital & Institute, Shenyang, China.
¹⁰Department of Urology, Xijing Hospital of Air Force Military Medical University, Xi'an, China.
¹¹Head and Neck, Genitourinary Department, Harbin Medical University Affiliated Cancer Hospital, Harbin, China.
¹²Department of Urology, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, China.
¹³Department of Urology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China.
¹⁴Department of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
¹⁵Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
¹⁶Department of Urology, The Southwest Hospital of Army Medical University, Chongqing, China.
¹⁷Department of Urology, Peking University First Hospital, Institute of Urology, Peking University, National Urological Cancer Center, Beijing, China.
¹⁸Department of Urology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, China.
¹⁹Department of Urology, Qilu Hospital of Shandong University, Jinan, China.
²⁰Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, China.
²¹Department of Urology, Shanghai Tenth People's Hospital, Shanghai, China.
²²Department of Urology, Peking University Third Hospital, Beijing, China.
²³Department of Oncology, The First Hospital of Jilin University, Changchun, China.
²⁴Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
²⁵Department of Urology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
²⁶Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²⁷Department of Oncology, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.
²⁸Department of Urology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
²⁹Department of Urology, Jiangxi Cancer Hospital, Nanchang, China.
³⁰Department of Urology, Chinese PLA General Hospital, Beijing, China.
³¹Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
³²Department of Urology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
³³Department of Urology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.
³⁴Department of Oncology, The First Affiliated Hospital of Shihezi University, Shihezi, China.
³⁵Department of Urology, The First Hospital of Lanzhou University, Lanzhou, China.
³⁶Department of Integrative Oncology, China-Japan Friendship Hospital, Beijing, China.
³⁷Department of Urology, The First Hospital of Jiaxing, The First Affiliated Hospital of Jiaxing University, Jiaxing, China.
³⁸Department of Oncology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, China.
³⁹Department of Clinical Medicine, Chia Tai Tianqing Pharmaceutical Group, Beijing, China.

⁰Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

The Lancet. Oncology +

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2025年9月4日

PubMedで要約を見る

まとめ

ベンメルストバルトとアノチニブは,スニチニブと比較して,進行性腎臓がん患者の無進行生存率を有意に改善しました. この新しい組み合わせはこの患者集団にとって望ましい新しい第一線治療の選択肢です

科学分野

腫瘍学
免疫療法
臨床試験

背景

進行した腎臓細胞癌 (RCC) は新しい治療戦略を必要とします.
PD-L1阻害は,高度なRCCでは未開拓の可能性を示しています.
この研究は,先端のRCC治療における新しい薬剤の必要性に対処しています.

研究の目的

ベンメルストーバルト (PD- L1 阻害剤) とアノチニブとスニチニブの有効性を比較する.
主要エンドポイントとして,不発症生存率 (PFS) を評価する.
進行したRCCにおける併用療法の安全性と耐性を評価する.

主な方法

中国での多センター,ランダム化,オープンラベル,第3相試験 (ETER100).
531人の治療前に進行したクリア細胞RCC患者はランダム化 (1: 1) された.
ベンメルストーバルトとアノチニブまたはスニチニブは,疾患の進行または容認できない毒性まで投与された.

主要な成果

ベンメルストバルト+アノチニブは,スニチニブ (9. 8ヶ月) と比べてPFSの中央値を有意に改善した (HR0. 53,p< 0. 0001).
プロトコル毎のPFSの中央値も組み合わせ (19. 0 vs 11. 0ヶ月) を好みました.
高血圧は,最も一般的なグレード3+の有害事象であり,重篤な有害事象は,併用アームで高かった.

結論

ベンメルストバルトとアノチニブは,第一線進行クリア細胞RCCにおいて,スニチニブよりも優れたPFSを示した.
この組み合わせは,進行したRCCの患者にとって新たな治療法となる可能性があります.
長期的な結果と安全性のさらなる評価が必要である.

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