China’s National Medical Products Administration (NMPA) has approved a combination of ELUNATE (fruquintinib) and TYVYT (sintilimab) for patients with advanced renal cell carcinoma whose disease has progressed following prior VEGFR-tyrosine kinase inhibitor (VEGFR-TKI) therapy.
The approval applies to patients with locally advanced or metastatic disease who have not previously received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy in the first-line setting.
The decision was based on results from the phase 3 FRUSICA-2 study, which evaluated fruquintinib combined with sintilimab against axitinib or everolimus monotherapy in second-line treatment.
The study met its primary endpoint of progression-free survival (PFS), with patients receiving the combination therapy achieving median PFS of 22.2 months compared with 6.9 months in the comparator arm.
Objective response rates were also higher in the combination group, while the safety profile was reported to be consistent with the known effects of each treatment.
Professor Dingwei Ye of Fudan University Shanghai Cancer Center said advances in targeted therapies and immunotherapy combinations were continuing to reshape treatment approaches in 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. Optimising the selection of treatment for individual patients is a key focus of clinical interest,” said the professor.
Kidney cancer remains a significant global health burden, with around 435,000 new diagnoses estimated worldwide in 2022. Approximately 90% of kidney tumours are renal cell carcinoma.
The approval represents the latest indication for sintilimab in China and expands use of the combination regimen following earlier approval in advanced endometrial cancer.
