1.0君实生物/en/js3333线路检测中心(中国)有限公司-Baidu百科rich600338Junshi Biosciences Announces Primary Endpoint Met in RENOTORCH Study of Toripalimab for 1st-line Treatment of Advanced Renal Cell Carcinoma
/wp-content/uploads/2023/05/微信图片_20230426182711.jpg35882004SHANGHAI, China, April 27, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the pre-specified interim analysis of the RENOTORCH study (NCT04394975) has been completed. RENOTORCH is a multi-center, randomized, open-label, active-controlled phase 3 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 (“RCC”). 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.