Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has announced that its multi-center, randomized, open, positive-controlled Phase III RENOTORCH study has reached pre-set endpoints at the interim analysis stage. The study evaluates the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with axitinib for the treatment of moderate to high-risk unresectable or distant metastatic renal cell carcinoma (RCC).
Significant Reduction in Disease Progression Risk and Improved ORR
The results demonstrated that compared to sunitinib, the first-line treatment of toripalimab combined with axitinib significantly reduced the risk of disease progression or death in patients with advanced RCC. Additionally, the combination therapy improved the overall response rate (ORR), a secondary endpoint of the study.
Safety Profile Consistent with Known Risks
The study found no new safety signals, and the safety data was consistent with known risks associated with the treatment. The independent data monitoring committee confirmed that the primary endpoint of the study, progression-free survival (PFS), had reached the efficacy threshold.
Regulatory Filing and First-Line Setting for Advanced RCC in China
Junshi Biosciences will engage in communications with the regulatory body regarding the market filing for the drug in the near term. The RENOTORCH study is notable as the first pivotal Phase III study for an immunotherapy in advanced RCC in China, where no PD-(L)1 combined with a VEGFR inhibitor has been approved for use in the first-line setting for advanced RCC.-Fineline Info & Tech
