Cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) combined with axitinib for the first-line treatment of advanced or metastatic non-clear renal cell carcinoma: A prospective, single-arm, phase Ib/II study.

• DOI: 10.1200/jco.2025.43.5_suppl.544
• Publication Date: 2025-02-18T14:40:47Z
• Authors: Xu Hu; Fengnian Zhao; Yuntian Chen; Junjie Zhao; Yifu Shi; Yanfeng Tang; Yongquan Wang; Xingming Zhang; Jiayu Liang; Jinge Zhao; Junru Chen; Qiang Wei; Xiang Li; Jiyan Liu; Ni Chen; Pengfei Shen; Jin Yao; Guangxi Sun; Zhenhua Liu; Hao Zeng
• Keywords: Axitinib; Tremelimumab

544 Background: Non-clear cell renal carcinoma (nccRCC) accounts for approximately 25% of all (RCC) and lacks standards care. More recent data suggests the efficacy anti-PD-(L)1 plus anti-CTLA-4 immune checkpoint inhibitors combined with tyrosine-kinase in RCC. Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 CTLA-4, showing manageable safety profile favorable clinical benefits. Here we explore cadonilimab combination axitinib patients advanced or metastatic nccRCC. Methods: Eligible had histologically confirmed nccRCC who not previously received systemic therapy. Patients (10 15 mg/kg q3w phase Ib, 10mg/kg II) (5mg bid) as first-line treatment until disease progression intolerant to treatment. The primary endpoints were objective response rate (ORR; RECIST v1.1). This study registered ClinicalTrials.gov, NCT05808608. Results: As October 1, 2024, 26 enrolled, median follow-up was 5.1 months (0.6-10.7 months). Twenty available assessment. Confirmed ORR 55% (11/20), control (DCR) 95% (19/20). progression-free survival (PFS) reached. All experienced treatment-related adverse events (TRAEs), grade≥3 TRAEs occurred 12 (46.2%) patients. Conclusions: demonstrated promising antitumoral toxicities trial an ongoing study, complete results are awaited after completion enrollment longer follow-up. Clinical information: NCT05808608 .