Core Viewpoint - The FRUSICA-2 study results indicate that the combination of fruquintinib and sintilimab may provide a valuable new treatment option for patients with advanced renal cell carcinoma, addressing significant unmet medical needs in this patient population [1][3]. Summary by Sections Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial designed to evaluate the efficacy and safety of fruquintinib combined with sintilimab compared to monotherapy with axitinib or everolimus for second-line treatment of advanced renal cell carcinoma [1]. - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy [1]. Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab group was 22.2 months, compared to 6.9 months for the axitinib/everolimus group (stratified hazard ratio [HR] 0.373; p < 0.0001) [2]. - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy (odds ratio 4.622; p < 0.0001) [2]. - The median duration of response (DoR) was 23.7 months for the combination group compared to 11.3 months for the monotherapy group [2]. - Efficacy benefits were observed across all prognostic risk groups as defined by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) [2]. Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments [2]. - The proportion of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) was 71.4% in the fruquintinib and sintilimab group, compared to 58.8% in the axitinib/everolimus group [2]. Regulatory Status - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3].
和黄医药(00013.HK)将于2025年欧洲肿瘤内科学会(ESMO)年会公布FRUSICA-2注册研究数据