The frontline use of toripalimab (Tuoyi) in combination with axitinib (Inlyta) has shown to be more effective than sunitinib (Sutent) monotherapy in treating patients with advanced renal cell carcinoma (RCC), according to the phase 3 RENOTORCH trial (NCT04394975). This trial, conducted across 47 Chinese medical centers, enrolled 421 patients with intermediate- to high-risk unresectable or metastatic RCC.
A prespecified interim analysis revealed that the toripalimab regimen significantly reduced the risk of disease progression or death compared to sunitinib. The Independent Data Monitoring Committee (IDMC) confirmed that the primary end point of progression-free survival (PFS) had met its predefined efficacy boundary. Additionally, toripalimab improved the overall response rate (ORR), a secondary end point, without introducing new safety signals.
Toripalimab is an anti-PD-1 monoclonal antibody that blocks the interactions between PD-1 and its ligands, PD-L1 and PD-L2, enhancing the immune system's ability to fight tumor cells. The RENOTORCH study's positive outcomes are expected to address the gap in renal cancer PD-L1 immunotherapy in China, offering new combination immunotherapy options for patients.
Eligibility for the trial required patients to have no prior systemic therapy after metastasis for RCC, among other criteria. The study excluded patients with prior treatment targeting PD-1, PD-L1, or CTLA-4, and those with additional malignancies requiring treatment in the last five years, except for certain conditions.
Detailed findings from the study are anticipated to be presented at a future international medical conference, further elucidating the benefits of this combination therapy for advanced RCC patients.
