Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial.

作者：Xiaotian Zhang, Yakun Wang, Xiaojun Xiang, Hongming Pan, Jingdong Zhang, Xiaobing Chen, Yi Ba, Ying Jieer, Yifu He, Xianli Yin, Huiting Xu, Xiao Li, Lian Liu, Juan Chen, Jiachi Ma, Lin Shen, Ting Liu, Wei Liu, Baiyong Li, Yu Xia · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.4012 · 被引用次数：7 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Lung Cancer Treatments and Mutations

4012 Background: Anti-PD-1 monoclonal antibody (mAbs) plus chemotherapy has become standard first-line therapy for patients (pts) with advanced/metastatic G/GEJ cancer. In this phase Ib/II study (NCT04982276), we assessed the safety and efficacy of cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination with pulocimab, an anti-VEGFR-2 mAb, and paclitaxel in G/GEJ cancer pts who failed immunochemotherapy. Methods: This study consisted of two parts: safety run-in (arms A, B and C, n = 6 each) and expansion (a randomized, double-blind phase II study). In safety part, pts received intravenous pulocimab 10mg/kg, every 2 weeks (Q2W) + paclitaxel 80 mg/m 2 , days 1, 8, 15 (arm A), or cadonilimab 10mg/kg + pulocimab 10mg/kg, Q2W (arm B), or cadonilimab 10mg/kg + pulocimab 10mg/kg + paclitaxel 150 mg/m 2 , Q3W (arm C). In expansion part, pts were randomly assigned at 1:1 ratio to receive cadonilimab 10mg/kg + pulocimab 10mg/kg + paclitaxel 150 mg/m 2 , Q3W (arm 1) or placebo + pulocimab + paclitaxel (arm 2). The primary endpoint was safety and objective response rate (ORR), secondary endpoints included progression-free survival (PFS) and overall survival (OS). Results: As of 30 Oct. 2023, a total of 77 pts were enrolled. In safety part (n = 18), dose-limiting toxicity (DLT) was observed in 1/6 pts in arm B, whereas no DLT was observed in either arm A or C. In expansion part, 59 pts were randomly assigned to arm 1 (n = 29) and arm 2 (n = 30). 6 pts were excluded due to treatment...