HUTCHMED and Innovent Biologics announced positive top-line results from the FRUSICA-2 Phase II/III trial. The trial investigated fruquintinib combined with sintilimab as a second-line treatment for advanced renal cell carcinoma (RCC) in China and successfully met its primary endpoint of progression-free survival. The combination also showed improvement in secondary endpoints, including objective response rate and duration of response.
This success is particularly important because it addresses the unmet need for effective second-line treatments for advanced RCC in China. While several first-line immune-oncology combination therapies are approved in the US, options are more limited in China, particularly for those who have progressed after first-line targeted therapy. This positive data positions the fruquintinib-sintilimab combination to potentially become a valuable new treatment option for these patients.
The FRUSICA-2 study was a randomized, open-label, active-controlled trial comparing the fruquintinib-sintilimab combination to axitinib or everolimus monotherapy. Previous Phase Ib/II data for this combination showed promising results, with a confirmed objective response rate of 60% and a disease control rate of 85% in previously treated patients. Full data from the FRUSICA-2 trial will be presented at an upcoming scientific conference.
This positive outcome paves the way for potential regulatory submissions in China for the fruquintinib-sintilimab combination in advanced RCC. This development could significantly alter the treatment landscape for this cancer in China, offering a new and potentially more effective second-line therapy for patients who have not responded adequately to prior treatments. This also strengthens the position of both HUTCHMED and Innovent in the oncology market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
