Innovent Biologics and HUTCHMED Announce Positive Results for Sintilimab and Fruquintinib in Renal Cell Carcinoma and Endometrial Cancer
On March 18, 2025, Innovent Biologics, Inc. and HUTCHMED Limited made a joint announcement regarding the successful results of their clinical trials for the combination of sintilimab and fruquintinib. Innovent is a leading biopharmaceutical company specializing in the development, manufacturing, and commercialization of high-quality medicines for various diseases, while HUTCHMED is a healthcare company focused on discovering, developing, and commercializing innovative therapeutics.
Sintilimab and Fruquintinib for Renal Cell Carcinoma
In the Phase 2/3 clinical trial, FRUSICA-2, sintilimab in combination with fruquintinib was tested as a second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China. The trial met its primary endpoint, which was progression-free survival (PFS) as assessed by blinded independent central review (BICR) based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). This means that the combination of the two drugs effectively delayed the progression of RCC in patients, providing hope for those with advanced stages of the disease.
Conditional Approval for Sintilimab and Fruquintinib in Endometrial Cancer
Additionally, the combination of sintilimab and fruquintinib received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This approval was based on data from the FRUSICA-1 study.
Impact on Patients
These developments are significant for patients with RCC and endometrial cancer, as they offer new treatment options for those who have exhausted other therapeutic avenues. The combination of sintilimab and fruquintinib has shown promise in delaying disease progression and providing a potential new hope for those with advanced stages of these diseases.
Impact on the World
Beyond the impact on individual patients, these approvals represent a step forward in the global fight against RCC and endometrial cancer. The collaboration between Innovent and HUTCHMED has led to the development of an effective treatment combination, which could potentially be adopted in other countries and regions. This could lead to improved patient outcomes and a reduction in the global burden of these diseases.
Conclusion
The successful outcomes of the FRUSICA-2 and FRUSICA-1 clinical trials for sintilimab and fruquintinib mark an important milestone in the treatment of RCC and endometrial cancer. These approvals offer new hope for patients with advanced stages of these diseases and represent a significant step forward in the global fight against these conditions. The collaboration between Innovent and HUTCHMED is a testament to the power of scientific innovation and the potential for collaboration to drive meaningful progress in healthcare.
- Innovent Biologics and HUTCHMED announce positive results from clinical trials for sintilimab and fruquintinib
- FRUSICA-2 trial meets primary endpoint of progression-free survival for RCC treatment in China
- Conditional approval granted in China for sintilimab and fruquintinib for advanced endometrial cancer
- New treatment options offer hope for patients with advanced RCC and endometrial cancer
- Collaboration between Innovent and HUTCHMED drives progress in the fight against these diseases
