The phase 3 RENOTORCH study is comparing the combination of the PD1-inhibitor toripalimab and axitinib with single-agent sunitinib in patients with renal cell carcinoma.
Findings from the phase 3 RENOTORCH study showed that adding the PD1-inhibitor toripalimab (Tuoyi) to axitinib (Inlyta) in the first-line setting reduced the risk of disease progression or death compared with sunitinib (Sutent) monotherapy in patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma (RCC).1
Data from a pre-specified interim analysis showed that the combination significantly improved progression-free survival (PFS) versus sunitinib, meeting the primary end point of the RENOTORCH study. The combination also led to improvements in secondary end points, including overall response rate (ORR). No new safety signals were reported compared with prior research involving the study drugs.
“Thanks to the collective efforts of the investigators, patients, [research and development] teams and many others, the RENOTORCH study has been a great success,” said Jianjun Zou, global research and development president of Junshi Biosciences, the developer of toripalimab, in the press release. “This study represents a crucial milestone for our company as an innovative Chinese pharmaceutical company that aims to address the nation’s unmet medical needs.”
RENOTORCH is a multi-center, randomized, open-label, active-controlled, phase 3 clinical study evaluating the efficacy and safety of the combination of toripalimab and axitinib vs sunitinib monotherapy for the first-line treatment of patients with intermediate to high-risk unresectable or metastatic RCC.2 It is the first pivotal phase 3 study of immunotherapy for patients with advanced RCC in China.
Enrolled individuals were randomly assigned in a 1:1 ratio to receive toripalimab in combination with either axitinib or sunitinib until disease progression or intolerable toxicity.
In the experimental arm, patients received toripalimab 240 mg intravenously every 3 weeks plus axitinib 5 mg orally twice daily. In the control arm, patients were given sunitinib 50 mg orally once daily for 4 weeks followed by off treatment for 2 weeks, or once daily for 2 weeks, followed by 1 week off treatment.
The primary endpoint is PFS, and secondary end points of the study include PFS as assessed by investigators, ORR, duration of response, disease control rate, overall survival, and safety.
Further details on the study data will be presented at an upcoming international academic conference.1
“We believe that RENOTORCH’s positive results will help bridge the gap in renal cancer PD-[L]1 immunotherapy in China, and we will take all the necessary steps to commercialize this achievement and provide new and effective combination immunotherapy options for domestic patients,” added Zou.
1. Junshi Biosciences announces primary endpoint met in RENOTORCH study of toripalimab for 1st-line treatment of advanced renal cell carcinoma. News Release. Shanghai Junshi Biosciences Co., Ltd. April 27, 2023. Accessed April 27, 2023. https://bit.ly/3n15orq
2. Study to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy in advanced renal cell cancer. ClinicalTrials.gov. Updated April 26, 2023. Accessed April 27, 2023. https://clinicaltrials.gov/ct2/show/NCT04394975