The HUTCHMED (China) Limited, a leading commercial-level, innovative biopharmaceutical company, declared its results from the FRUSICA-2 registration clinical trial of the sintilimab and fruquintinib merger for the advanced or metastatic renal cell carcinoma patients. The results of its phase 3 part of the study will be out on 17th October 2025 at the European Society for Medical Oncology (ESMO) congress meeting in Berlin, Germany.
The FRUSICA-2 is an open-label, active-controlled controlled and randomized registration study examining the safety and efficacy of fruquintinib in merger with everolimus monotherapy or sintilimab versus axitinib to introduce an approach to the second-line treatment of upgraded renal cell carcinoma (NCT05522231). Around 234 patients were allotted to a group that took sintilimab plus fruquintinib merger therapy, or to a group that took everolimus or axitinib monotherapy. As per the progression-free survival (PFS) final analysis, mitigation was shown on 17th February 2025; the median follow-up was around 16.6 months. The sintilimab and fruquintinib combination’s safety profile was consistent and tolerable with the familiar profiles of every single treatment.
The co-leading principal investigator of the FRUSICA-2 study and Fudan University Shanghai Cancer Center’s Professor Dingwei Ye said, “The FRUSICA-2 trial results contain proof that sintilimab and fruquintinib might provide a precious new treatment alternative for advanced renal cell carcinoma patients. These findings highlight the combination’s capability to identify a crucial unmet need for this patient group. Following that serves a continuous chain of benefits throughout the prognostic risk population and different patient profiles.”
The co-leading principal investigator of the FRUSICA-2 study and Peking University First Hospital’s Professor Zhisong He said, “The FRUSICA-2 study advises that sintilimab and fruquintinib have the potential to play a major role in reframing the second-line treatment approach for advanced renal cell carcinoma. These results indicate the merger's capability to improve clinical outcomes, providing a new alternative for dealing with this challenging disease.”
Backed up by the data from FRUSICA-2, a new drug application (NDA) has been approved for review by the National Medical Products Administration (NMPA) of China. With this review approval, the FRUSICA-2 study data will support at least a fraction of its innovation and understanding of the clinical level advancement for advanced or metastatic renal cell carcinoma. The positive results have paved the way for new drug development.
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
