HUTCHMED (00013) announced the results of the FRUSICA-2 registration study evaluating fruquintinib in combination with sintilimab for treating patients with locally advanced or metastatic renal cell carcinoma. The Phase III portion results will be presented on Friday, October 17, 2025, at the European Society for Medical Oncology (ESMO) Annual Meeting in Berlin, Germany.

FRUSICA-2 is a randomized, open-label, positive-controlled registration study designed to evaluate the efficacy and safety of fruquintinib plus sintilimab combination therapy versus axitinib or everolimus monotherapy as second-line treatment for advanced renal cell carcinoma (NCT05522231).

A total of 234 patients were randomly assigned to receive either the fruquintinib plus sintilimab combination therapy or axitinib or everolimus monotherapy. At the final analysis cutoff date of February 17, 2025, for progression-free survival (PFS), the median follow-up time was 16.6 months.

The median PFS assessed by blinded independent central review (BICR) was 22.2 months for fruquintinib plus sintilimab versus 6.9 months for the axitinib/everolimus group (stratified hazard ratio [HR] 0.373; stratified log-rank test p <0.0001). The objective response rates (ORR) were 60.5% versus 24.3% respectively (odds ratio 4.622, p <0.0001), with median duration of response (DoR) of 23.7 months versus 11.3 months.

As of the data cutoff, overall survival data continues to mature with approximately 20% maturity. Efficacy benefits were observed across all prognostic risk groups according to International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.

The combination of fruquintinib and sintilimab demonstrated a tolerable safety profile consistent with the known characteristics of each treatment. The incidence of grade 3 or higher treatment-emergent adverse events (TEAEs) was 71.4% in the fruquintinib plus sintilimab group compared to 58.8% in the axitinib/everolimus group.

Professor Ye Dingwei from Fudan University Shanghai Cancer Center, co-principal investigator of the FRUSICA-2 study, stated: "The FRUSICA-2 study results provide compelling evidence that fruquintinib combined with sintilimab has the potential to become a valuable new treatment option for patients with advanced renal cell carcinoma. These data demonstrate that this combination therapy can address important unmet medical needs in this patient population, bringing consistent benefits to patients with different clinical characteristics and prognostic risks."

Professor He Zhisong from Peking University First Hospital, co-principal investigator of the FRUSICA-2 study, commented: "The FRUSICA-2 study shows that the combination therapy of fruquintinib and sintilimab has the potential to transform second-line treatment strategies for advanced renal cell carcinoma. This combination therapy demonstrates the potential to improve clinical outcomes, providing new treatment options for addressing this challenging disease."

Based on the FRUSICA-2 study data, China's National Medical Products Administration (NMPA) 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 failed previous systemic treatment.