Key Takeaways:
HUTCHMED and Innovent Biologics received approval from China’s National Medical Products Administration for their two-drug combination to treat advanced renal cell carcinoma, after a study showed it reduced the risk of disease progression or death by 63 percent.
“The approval of the fruquintinib and sintilimab combination underscores its potential to address the pressing medical needs of patients with this challenging disease,” said Professor Dingwei Ye of Fudan University Shanghai Cancer Center, a lead investigator of the study.
The approval for the combination of fruquintinib, sold as Elunate, and sintilimab, sold as Tyvyt, was supported by data from the FRUSICA-2 trial. The median progression-free survival for patients taking the combination was 22.2 months, compared to 6.9 months for those on axitinib or everolimus, according to a statement from the companies. The objective response rate was 60.5 percent versus 24.3 percent for the control arm.
The approval provides a new second-line treatment option for patients in China with locally advanced or metastatic renal cell carcinoma, a setting where therapeutic choices are limited. For Innovent, the decision marks the 10th approved indication for its PD-1 inhibitor Tyvyt, further cementing its role in China’s oncology market.
The FRUSICA-2 study was a randomized, open-label trial evaluating the efficacy of the fruquintinib and sintilimab combination. Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (VEGFR-1, -2, and -3), which are pivotal in tumor angiogenesis. Sintilimab is a PD-1 inhibitor that reactivates T-cells to fight cancer cells.
The positive results from the trial were consistent across all prognostic risk groups defined by the International mRCC Database Consortium criteria. The safety profile of the combination was in line with the known profiles of each individual drug.
An estimated 74,000 new patients were diagnosed with kidney cancer in China in 2022, with about 90 percent of those tumors being renal cell carcinoma. This approval targets patients who have failed prior vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy.
The approval strengthens HUTCHMED’s and Innovent’s oncology portfolios in China. Fruquintinib is already approved in China, the US, Europe, and Japan for metastatic colorectal cancer. This new combination approval opens a significant new revenue stream for both companies in the world’s second-largest pharmaceutical market. Investors will watch for sales uptake and any further combination studies the partners may pursue.
This article is for informational purposes only and does not constitute investment advice.
