Core Insights - 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] Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial designed to evaluate the efficacy and safety of fruquintinib and sintilimab compared to axitinib or everolimus as second-line treatments for advanced renal cell carcinoma [1] - A total of 234 patients were randomly assigned to receive either the combination therapy or monotherapy with axitinib or everolimus, with a median follow-up time of 16.6 months as of the final analysis cutoff date [1] Efficacy Results - The median progression-free survival (PFS) for the fruquintinib and sintilimab combination was 22.2 months, compared to 6.9 months for the axitinib/everolimus group, with a stratified hazard ratio (HR) of 0.373 and a p-value of less than 0.0001 [2] - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy group, with an odds ratio of 4.622 and a p-value of less than 0.0001 [2] - The median duration of response (DoR) was 23.7 months for the combination therapy compared to 11.3 months for the monotherapy group [2] Safety Profile - The combination therapy demonstrated a tolerable safety profile, consistent with known characteristics of the treatments, with 71.4% of patients experiencing grade 3 or higher treatment-emergent adverse events (TEAEs) compared to 58.8% in the axitinib/everolimus group [2] Regulatory Progress - Based on the FRUSICA-2 study data, the National Medical Products Administration of China has accepted the new drug application for the combination therapy of fruquintinib and sintilimab for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3]

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].