Interim analysis of the RENOTORCH study of toripalimab plus axitinib meets predefined boundary in renal cell carcinoma.- Shanghai Junshi Biosciences

RENOTORCH is a multi-center, randomized, open-label, active-controlled phase III clinical study evaluating toripalimab in combination with axitinib for the first-line treatment of patients with intermediate to high risk, unresectable or distant metastatic renal cell carcinoma. The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of progression free survival (“PFS”, based on independent radiographic review) has met the pre-defined efficacy boundary. Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental new drug application in the near future.

As the first pivotal phase III study of immunotherapy for patients with advanced RCC in China, RENOTORCH is a multi-center, randomized, open-label, active-controlled study aiming to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy for the first-line treatment of patients with intermediate to high-risk unresectable or metastatic RCC. Based on the interim analysis of the study, toripalimab in combination with axitinib for the first-line treatment of patients with advanced RCC significantly reduced the risk of disease progression or death compared to sunitinib monotherapy, while improving secondary endpoints such as ORR. The safety profile of toripalimab in the study was consistent with known risks, and no new safety signals were identified. Further details on the study data will be presented at an upcoming international academic conference.

The RENOTORCH study is a multi-center, randomized, open-label, active-controlled phase III study aiming to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy for the first-line treatment of patients with intermediate to high-risk unresectable or metastatic RCC. 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. The primary endpoint is PFS as assessed by the Independent Radiographic Review Committee, and secondary endpoints include PFS as assessed by investigators, ORR as assessed by IRC or investigators, duration of response (DOR) and disease control rate (DCR), OS, safety profile etc.