Globally, renal carcinoma is the third most common type of malignancy in the urinary system, and RCC accounts for 80%-90% of all cases. According to data published in the Chinese Medical Journal, in 2022, there were approximately 77,000 new cases of renal carcinoma and 46,000 deaths due to this disease in China. Approximately one-third of the renal carcinoma patients had distant metastasis at initial diagnosis, while 20%-50% of the patients with localized tumors developed distant metastases after nephrectomy. According to the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), patients with low, medium and high-risk metastatic RCC who were receiving anti-vascular targeted treatment demonstrated median overall survival (“OS”) rates of 35.3, 16.6 and 5.4 months, respectively. Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.

This supplemental new drug application is mainly based on the RENOTORCH study (NCT04394975). As the first pivotal phase 3 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. The study was jointly led by principal investigators Professor Jun GUO of the Peking University Cancer Hospital and Professor Yiran HUANG of Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine.

According to the study’s interim analysis, 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.

Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences, expressed her enthusiasm regarding the acceptance of this application. “Currently, China’s primary approach towards treating advanced RCC still relies heavily on targeted monotherapy using TKIs, and unfortunately, the benefits from this treatment are minimal for patients. We are therefore immensely excited about the RENOTORCH study, a Chinese-led clinical trial conducted in the Chinese population that has demonstrated that combining toripalimab with axitinib can significantly prolong patients’ progression-free survival (PFS). This means that the field of renal cancer treatment in China may soon welcome its very first ‘immune-targeting’ combination therapy. We will actively communicate and collaborate with regulatory authorities and hope to soon provide more effective and accessible treatment options to Chinese patients.”