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A phase Ib/II study of cadonilimab (PD-1/CTLA-4 bispecific antibody) plus anlotinib as first-line treatment in patients with advanced non-small cell lung cancer

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机构： [1]The Second Department of Thoracic Medicine, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [2]Department of Oncology, Sichuan Cancer Hospital, Chengdu, China. [3]The Second Ward, Oncology Department, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [4]Department of Thoracic Oncology, Fujian Cancer Hospital, Fuzhou, China. [5]Department of Thoracic Oncology, Tongji Hospital Affiliated to Tongji Medical College of HUST, Wuhan, China. [6]Department of Oncology, Chenzhou First People's Hospital, Chenzhou, China. [7]Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China. [8]Department of Medical Oncology, The Second Affiliated Hospital of Kunming Medical University, Kunming, China. [9]Department of Oncology, Hunan Provincial People's Hospital /The First Affiliated Hospital of Hunan Normal University, Changsha, China. [10]The Second Department of Respiratory Medicine, Henan Cancer Hospital, Zhengzhou, China. [11]Department of Oncology, The First People's Hospital of Changde City, Changde, China. [12]Department of Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [13]Akeso Biopharma, Inc, Zhongshan, China.

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Cadonilimab is a bispecific antibody that simultaneously targets programmed cell death receptor-1 and cytotoxic T lymphocyte-associated antigen-4. This study aimed to assess the safety and efficacy of cadonilimab plus anlotinib for the first-line treatment of advanced non-small cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.Patients received cadonilimab 15 mg/kg and 10 mg/kg every three weeks (Q3W) plus anlotinib at doses of 10 or 12 mg once daily for two weeks on a one-week-off schedule. The primary endpoints included safety and objective response rate (ORR).Sixty-nine treatment-naïve patients received cadonilimab 15 mg/kg Q3W combination (n = 49) and 10 mg/kg Q3W combination (n = 20). Treatment-related adverse events (TRAEs) were reported in 48 (98.0%) and 19 (95.0%) patients, with grade ≥3 TRAEs occurring in 29 (59.2%) and five (25.0%) patients, respectively. TRAEs leading to cadonilimab discontinuation occurred in eight (16.3%) and one (5.0%) patients in the cadonilimab 15 mg/kg Q3W and 10 mg/kg Q3W dosing groups. The confirmed ORRs were 51.0% (25/49) and 60.0% (12/20) accordingly.Cadonilimab 10 mg/kg Q3W plus anlotinib showed manageable safety and promising efficacy as a first-line chemo-free treatment for advanced NSCLC.NCT04646330.© 2023. The Author(s), under exclusive licence to Springer Nature Limited.

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大类 | 1 区

医学

小类 | 2 区肿瘤学

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无

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Q1 ONCOLOGY

影响因子： 6.4 最新[2023版] 8.1 最新五年平均 6.4 出版当年[2023版] 0 出版当年五年平均 6.4 出版前一年[2023版]

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第一作者机构： [1]The Second Department of Thoracic Medicine, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.

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