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]. Group 1: Study Overview - The FRUSICA-2 study is a randomized, open-label, positive-controlled registration trial aimed at evaluating the efficacy and safety of fruquintinib combined with sintilimab compared to axitinib or everolimus monotherapy 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]. Group 2: 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, with a stratified hazard ratio (HR) of 0.373 and a p-value of <0.0001 [2]. - The objective response rate (ORR) was 60.5% for the combination therapy versus 24.3% for the monotherapy, with an odds ratio of 4.622 and a p-value of <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]. Group 3: 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]. Group 4: 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 for patients with locally advanced or metastatic renal cell carcinoma who have previously failed systemic treatment [3].