China Approves Sintilimab-Fruquintinib Combination for Advanced Renal Cell Carcinoma
核心洞察
China's NMPA has approved the combination of sintilimab (TYVYT®) and fruquintinib (ELUNATE (搜索)®) for second-line treatment of locally advanced or metastatic renal cell carcinoma patients who failed prior VEGFR (搜索)-TKI therapy.
The FRUSICA-2 Phase III trial demonstrated a 63% reduction in disease progression risk, with median progression-free survival extending to 22.2 months versus 6.9 months for standard therapy.
This approval marks the 10th indication for sintilimab and addresses critical unmet medical needs in China's advanced renal cell carcinoma treatment landscape.
China's National Medical Products Administration (NMPA) has granted approval for the combination of sintilimab (TYVYT®) and fruquintinib (ELUNATE (搜索)®) as second-line treatment for patients with locally advanced or metastatic renal cell carcinoma. The approval specifically targets patients who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFR (搜索)-TKI) therapy and have not received PD-1 (搜索) or PD-L1 (搜索) inhibitor therapy in the first-line setting.
The regulatory decision, announced jointly by Innovent Biologics (搜索) and HUTCHMED on May 21, 2026, is supported by compelling data from the FRUSICA-2 registration study, which demonstrated a 63% reduction in the risk of disease progression or death compared to standard therapy.
FRUSICA-2 Trial Results Show Significant Efficacy
The Phase III FRUSICA-2 study, a randomized, open-label, active-controlled registration trial, evaluated the efficacy and safety of sintilimab combined with fruquintinib versus axitinib or everolimus monotherapy for second-line treatment of locally advanced or metastatic renal cell carcinoma. Results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
As of the progression-free survival (PFS) final analysis cutoff of February 17, 2025, with a median follow-up of 16.6 months, the combination therapy achieved a median PFS of 22.2 months compared to 6.9 months with axitinib/everolimus (stratified hazard ratio 0.373; stratified log-rank p<0.0001). The objective response rate was 60.5% versus 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response was 23.7 months versus 11.3 months, respectively.
Efficacy benefits were observed across all prognostic risk groups as defined by the International mRCC Database Consortium (IMDC) criteria. Overall survival data were still evolving at the time of data cutoff with approximately 20% maturity. The safety profile of the combination was consistent with the known profiles of each individual treatment.
Clinical Significance for Advanced Renal Cell Carcinoma
"The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Optimizing the selection of treatment for individual patients is a key focus of clinical interest," said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and co-lead Principal Investigator of the FRUSICA-2 study. "The approval of the sintilimab and fruquintinib combination underscores its potential to address the pressing medical needs of patients with this challenging disease."
Professor Zhisong He of Peking University First Hospital and co-lead Principal Investigator of the FRUSICA-2 study added, "The FRUSICA-2 trial results provided compelling evidence that the sintilimab and fruquintinib combination could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma. We are optimistic about the clinical implications of this approval as we strive to provide effective treatment options for patients."
Addressing Unmet Medical Needs in China
The approval addresses significant unmet medical needs in China's oncology landscape. Approximately 74,000 new patients were diagnosed with kidney cancer in China in 2022, with renal cell carcinoma accounting for approximately 90% of kidney tumors. Globally, an estimated 435,000 new patients were diagnosed with kidney cancer in 2022.
"This approval reaffirms our deep commitment to delivering innovative therapies to patients facing advanced renal cell carcinoma in China, where second-line treatment options remain limited," said Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED.
Dr. Hui Zhou, Chief R&D Officer of Oncology of Innovent, stated: "The approval is a significant milestone for patients with advanced renal cell carcinoma in China. It further validates the potential of the sintilimab plus fruquintinib combination regimen, now approved for two difficult-to-treat cancers. We are also proud to achieve the 10th approved indication for our sintilimab (TYVYT®), and remain committed to advancing clinical value optimization to benefit an even broader population of cancer patients."
Drug Mechanisms and Previous Approvals
Sintilimab is a PD-1 (搜索) immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. The drug binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/PD-L1 (搜索) pathway, and reactivates T-cells to kill cancer cells.
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (VEGFR-1 (搜索), -2, and -3). The drug was designed with enhanced selectivity that limits off-target kinase activity, allowing for sustained target inhibition and flexibility for combination therapy use.
The combination of fruquintinib and sintilimab previously received conditional approval in China for treating patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation. Fruquintinib is also approved as monotherapy for metastatic colorectal cancer in China and has received approval in the US, Europe, Japan, and other countries under the brand name FRUZAQLA®.