Abstract 303P
Background
The phase II CABOSUN trial demonstrated significant clinical benefits of cabozantinib, including median progression-free survival (PFS) and objective response rate (ORR) over sunitinib in intermediate or poor-risk advanced renal cell carcinoma (RCC). Additionally, the phase III CHECKMATE-9ER study showed significant advantages of cabozantinib plus nivolumab over sunitinib in terms of PFS and overall survival (OS) for advanced RCC. This study presents the first real-world data in Taiwan, evaluating survival, response, and safety in first-line treatment of advanced RCC with cabozantinib versus cabozantinib plus nivolumab.
Methods
This retrospective, multi-institutional study utilized the Chang Gung Medical Foundation cancer registry, including patients with advanced RCC who received at least one dose of cabozantinib or cabozantinib plus nivolumab between 2020 and 2023.
Results
In total, data from 41 eligible patients were included in the analysis, with 21 patients receiving cabozantinib plus nivolumab and 20 patients receiving cabozantinib. The median PFS was not reached in the cabozantinib plus nivolumab group, while it was 6.3 months in the cabozantinib group (Hazard ratio, 0.38; 95% CI 0.15 to 0.94; P<0.05). Median OS was not reached in the cabozantinib plus nivolumab group and 11.4 months in the cabozantinib group (Hazard ratio, 0.22; 95% CI 0.06 to 0.82; P<0.05). The objective response rate (ORR) and disease control rate (DCR) were 52.2% and 94.7%, respectively, in the cabozantinib plus nivolumab group, and 20% and 65% in the cabozantinib group. The most common adverse events (AEs) in the cabozantinib plus nivolumab group were hand-foot skin reaction (47.6%), fatigue (38.1%), and diarrhea (28.6%). In the cabozantinib alone group, the most common AEs were fatigue (45%), diarrhea (40%), and hand-foot skin reaction (40%).
Conclusions
In this real-world study in Taiwan, cabozantinib plus nivolumab exhibited significant benefits over cabozantinib alone regarding PFS, OS, and ORR in the first-line treatment of advanced renal cell carcinoma.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Division of Oncology, Chang Gung Medical Foundation.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.