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.

Autor: Chen, Bolin, Yao, Wenxiu, Li, Xingya, Lin, Gen, Chu, Qian, Liu, Hailong, Du, Yingying, Lin, Jie, Duan, Huaxin, Wang, Huijuan, Xiao, Zemin, Sun, Hong, Liu, Liyu, Xu, Li, Xu, Yan, Xu, Fang, Kong, Yi, Pu, Xingxiang, Li, Kang, Wang, Qianzhi
Zdroj: British Journal of Cancer; Feb2024, Vol. 130 Issue 3, p450-456, 7p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index