Fruzaqla and Tyvyt Combo Shows Improved Outcomes in Advanced Kidney Cancer

Patients with advanced renal cell carcinoma whose disease has progressed on first-line therapies may benefit from the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab), according to data from the FRUSICA-2 registration trial, which were shared in a press release from HUTCHMED (China) Limited.

More details on these findings will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress, where investigators will highlight the phase 3 study that led to significant improvements in progression-free survival for patients receiving the combination compared with standard monotherapies.

FRUSICA-2 is a randomized, open-label study comparing Fruzaqla plus Tyvyt with Inlyta (axitinib) or everolimus monotherapy in patients with locally advanced or metastatic renal cell carcinoma who had previously received treatment. A total of 234 patients were enrolled, and the final analysis for progression-free survival included a median follow-up of 16.6 months. Median progression-free survival assessed by blinded independent central review was 22.2 months for the Fruzaqla and Tyvyt group versus 6.9 months for Inlyta (axitinib) or Afinitor (everolimus). The objective response rate was 60.5% versus 24.3%, and the median duration of response was 23.7 months versus 11.3 months, respectively. Benefits were consistent across all prognostic risk groups, according to the news release.

“The FRUSICA-2 trial results provide compelling evidence that Fruzaqla and Tyvyt may offer a valuable new treatment option for patients with advanced renal cell carcinoma,” Dr. Dingwei Ye, professor at Fudan University Shanghai Cancer Center and co-leading principal investigator of the FRUSICA-2 study, said in the news release. “These findings show the combination’s potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups.”

Safety and Tolerability of Fruzaqla Plus Tyvyt

The combination of Fruzaqla and Tyvyt was generally tolerable, with a safety profile consistent with each drug individually. Grade 3 (severe) or higher treatment-emergent side effects occurred in 71.4% of patients in the combination group compared with 58.8% in the Inlyta or Afinitor group. While side effects were noted, the overall benefits in blood cancer control and progression-free survival highlight a potential new treatment for patients with limited options after first-line therapy, investigators report.

“The FRUSICA-2 study suggests that Fruzaqla and Tyvyt could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma,” Dr. Zhisong He, professor at Peking University First Hospital and co-leading principal investigator of the study, added in the release. “These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease.”

Next Steps and Regulatory Review of Fruzaqla and Tyvyt

Based on FRUSICA-2 results, a new drug application for the combination of Fruzaqla and Tyvyt in patients with locally advanced or metastatic renal cell carcinoma who failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA).

Fruzaqla is an oral selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR-1, -2, and -3), designed to limit off-target activity and sustain tumor angiogenesis inhibition. It is co-developed in China by HUTCHMED and Eli Lilly under the brand Elunate and has established approvals in metastatic colorectal cancer and advanced endometrial cancer in specific settings.

Kidney cancer remains a serious health concern worldwide, with approximately 435,000 new diagnoses in 2022, including an estimated 74,000 in China. Approximately 90% of kidney tumors are renal cell carcinoma.

Overall, patients with advanced renal cell carcinoma who have progressed on first-line therapies, Fruzaqla and Tyvyt may represent an investigational treatment that could expand therapeutic options, the news release concludes.

Reference

1. HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress, by HUTCHMED (China) Limited. News release; Oct. 13, 2025.

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