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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Background: 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.
Methods: 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).
Results: 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.
Conclusions: Cadonilimab 10 mg/kg Q3W plus anlotinib showed manageable safety and promising efficacy as a first-line chemo-free treatment for advanced NSCLC.
Clinicaltrials:
Gov Identifier: NCT04646330.
Feng D, Jiang H, Chen G, Guan W, Yi L, Zhu Y Front Immunol. 2024; 15:1485358.
PMID: 39717770 PMC: 11663897. DOI: 10.3389/fimmu.2024.1485358.
Yu H, Lin J, Chen J, Chen L, Zou J, Liu B Front Immunol. 2024; 15():1494138.
PMID: 39660134 PMC: 11628523. DOI: 10.3389/fimmu.2024.1494138.
Next-generation immunotherapy: igniting new hope for lung cancer.
Li M, Chan A, Mok K, Chan L, Mok T Ther Adv Med Oncol. 2024; 16:17588359241302021.
PMID: 39649017 PMC: 11624561. DOI: 10.1177/17588359241302021.
Advances in the Management of Lung Cancer Brain Metastases.
Hockemeyer K, Rusthoven C, Pike L Cancers (Basel). 2024; 16(22.
PMID: 39594735 PMC: 11593022. DOI: 10.3390/cancers16223780.
Lun J, Ma G, Wang X, Wang Q Immunotherapy. 2024; 16(16-17):1015-1019.
PMID: 39258789 PMC: 11492687. DOI: 10.1080/1750743X.2024.2394405.