RENOTORCH Study of Toripalimab and Axitinib Meets Primary End Point in RCC

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The primary end point of progression free survival (PFS) has met the pre-defined efficacy boundary, according to the prespecified interim analysis of the RENOTORCH study (NCT04394975) evaluating toripalimab (Tuoyi) in combination with axitinib (Inlyta) for the first-line treatment of patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma (RCC).¹

In the interim analysis of the RENOTORCH study, the combination of toripalimab with axitinib for the first-line treatment of patients with advanced RCC significantly reduced the risk of disease progression or death vs sunitinib monotherapy. The combination also led to improvements in the secondary end points, including overall response rate (ORR). Regarding safety, the safety profile of toripalimab determined in the trial was consistent with known risks. Additionally, no new safety signals were identified.

With the phase 3 trial completed, Junshi Biosciences will discuss matters related to the supplemental new drug application with regulatory authorities in the near future.

“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, 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 (DOR), disease control rate (DCR), 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.

REFERENCES:

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

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