HUTCHMED (China) Limited and Innovent Biologics, Inc. announced that the China National Medical Products Administration has approved the combination of ELUNATE (fruquintinib) with TYVYT (sintilimab injection) for patients with locally advanced or metastatic renal cell carcinoma who have progressed on prior VEGFR-TKI therapy and have not received PD-1/PD-L1 inhibitors in the first line.

The approval is underpinned by the Phase III FRUSICA-2 trial. At a median follow-up of 16.6 months, fruquintinib plus sintilimab reduced the risk of disease progression or death by 63% versus axitinib or everolimus monotherapy (hazard ratio 0.373; p<0.0001). Median progression-free survival reached 22.2 months with the combination, compared with 6.9 months for the control arm. Objective response rate was 60.5% versus 24.3% (odds ratio 4.622; p<0.0001), and median duration of response was 23.7 months versus 11.3 months. Overall survival data were immature at ~20% maturity. Safety findings aligned with the established profiles of each agent.

Fruquintinib is a highly selective oral inhibitor of VEGFR-1/2/3, co-developed and commercialized in China by HUTCHMED and Eli Lilly under the brand name ELUNATE. It is already approved in China for previously treated metastatic colorectal cancer and has gained overseas approvals—marketed by Takeda as FRUZAQLA—for the same indication. The fruquintinib-sintilimab pairing also holds conditional approval in China for pMMR endometrial cancer.

Sintilimab, marketed as TYVYT in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly. The renal cell carcinoma authorization marks its tenth approved indication in China.

Kidney cancer accounted for an estimated 0.44 million new cases globally and 0.07 million in China during 2022, with renal cell carcinoma comprising about 90% of tumors, underscoring the need for additional therapeutic options.

Company executives highlighted the decision as validation of the combination strategy and a step toward expanding treatment choices for Chinese patients with advanced renal cell carcinoma.