Cadonilimab in combination with ivonescimab and chemotherapy as first-line (1L) therapy in patients with advanced gastric (G) or gastroesophageal junction adenocarcinoma (GEJA).

作者：Guangyu Wang, Chunhui Zhang, Jiebing Tang, Zhigang Ma, Dan Su, Yanqiao Zhang · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.e16037 · 被引用次数：1 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Esophageal Cancer Research and Treatment

e16037 Background: Cadonilimab (AK104), an anti-PD-1/CTLA-4 bispecific antibody, plus chemotherapy (chemo) significantly improved OS versus chemo and had a tolerable safety profile in 1L treatment of advanced G/GEJA patients (pts), including those with low PD-L1 expression. Currently, it has been approved by NMPA. Ivonescimab (AK112), approved in China, is a novel bispecific antibody against PD-1 and VEGF and has shown a clinically significant improvement in efficacy with favorable safety for advanced NSCLC in two phase 3 studies (HARMONi-2 and HARMONi-A). Here, we presented the preliminary safety and efficacy of AK104 combined with AK112 and chemo in previously untreated advanced G/GEJA. Methods: Pts with previously untreated advanced G/GEJA were enrolled. The phase II trial consisted of a dose escalation (part 1) and a dose expansion (part 2). Eligible pts were firstly enrolled into sequential part 1 including 10mg/kg and 15mg/kg AK104 (Q6W, D8) combined with AK112 (20mg/kg, Q3W, D1) and chemo (SOX or XELOX) following the conventional 3+3 design. If the starting dose of 10mg/kg AK104 led to ≥2 dose-limiting toxicities (DLTs), 6mg/kg AK104 would be administered. After the part 1 completed, eligible pts were enrolled into the part 2 and received AK104 (the recommended dose, Q6W, D8) combined with AK112 (20 mg/kg, Q3W, D1) and chemo (SOX or XELOX). The primary outcomes were safety and ORR. Secondary endpoints were DCR, PFS, OS, biomarkers of drug activity and pharmacokinetics....