China News Service, Shanghai, April 8 (Reporter Chen Jing) Kidney cancer is the third most common malignant tumor of the urinary system in the world, and renal cell carcinoma (RCC) accounts for 80% to 90% of all kidney cancer cases.
The reporter learned on the 8th that toripalimab injection (Tuoyi®), independently developed by a Chinese innovative pharmaceutical company, was approved by the State Food and Drug Administration for first-line treatment of renal cell carcinoma. In the future, toripalimab injection (Tuoyi®) combined with axitinib can be used as first-line treatment for patients with intermediate- and high-risk unresectable or metastatic renal cell carcinoma. Previously, no immunotherapy for kidney cancer had been approved in China.
Professor Huang Yiran from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine said on the same day: "The treatment options for advanced renal cancer are limited, especially the prognosis for intermediate and high-risk patients is very unsatisfactory. The approval of toripalimab combined with axitinib therapy fills the gap It has filled the gaps in first-line immunotherapy for renal cancer in the Chinese population. Compared with targeted drug monotherapy, toripalimab target-immune combination therapy can significantly improve the PFS (progression-free survival) of patients, and will provide a great opportunity for the majority of advanced renal cancer patients in China. Patients bring good news.”
It is reported that about one-third of renal cancer patients have already developed distant metastasis when first diagnosed, while 20%-50% of localized patients will still develop distant metastasis after nephrectomy. Based on the risk grading of the International Metastatic Renal Cell Carcinoma Database Consortium, the median overall survival (OS) of patients with low-risk, intermediate-risk, and high-risk metastatic RCC who received antivascular targeted therapy were 35.3, 16.6, and 5.4 months, respectively. Therefore, compared with low-risk patients, patients with intermediate- and high-risk advanced RCC have more urgent clinical needs for new treatment options.
It is reported that the approval of this new indication is mainly based on the results of a multi-center, randomized, open, active drug-controlled phase III clinical study. This RENOTORCH study was led by Professor Guo Jun of Peking University Cancer Hospital and Shanghai Jiao Tong University School of Medicine. Professor Huang Yiran of the Affiliated Renji Hospital serves as the principal investigator. It is carried out in 47 clinical centers across the country and is a key phase III clinical study of immunotherapy for advanced renal cancer.
Professor Guo Jun from Peking University Cancer Hospital said: "At the global level, targeted combination immunotherapy has become the standard treatment for advanced renal cancer. However, in China, no relevant therapy has been approved in this field. This time, toripalimab The approval of the indication opens a new chapter in the target-immune combination for advanced renal cancer in China, which will completely rewrite the clinical practice of advanced renal cancer in China, and more importantly, it can bring new treatment options to intermediate and high-risk patients."
Dr. Zou Jianjun, general manager and CEO of Junshi Biotech, said: "The company will continue to be based on the clinical needs of the Chinese people and continue to invest in innovative research and development, so that Chinese patients can obtain better quality of life and longer-term survival benefits." (End)