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Junshi Biosciences Obtains Approval for sNDA of Toripalimab for First-Line Renal Cancer Treatment

Monday, April 08, 2024

Shanghai Junshi Biosciences Co., Ltd, a leading biopharmaceutical company dedicated to innovating therapies, has announced the approval of a supplemental new drug application (sNDA) for toripalimab (JS001) in combination with axitinib for the initial treatment of medium to high-risk unresectable or metastatic renal cell carcinoma (RCC) by the National Medical Products Administration (NMPA) in China.

Renal carcinoma, being the third most common urinary system malignancy globally, with RCC accounting for 80% to 90% of cases, poses a significant health burden in China. In 2022 alone, there were about 77,000 new cases and 46,000 deaths due to renal carcinoma in China. The need for new treatment options, especially for medium to high-risk patients, is evident.

The sNDA approval was based on data from the RENOTORCH study, a pivotal Phase 3 clinical trial led by principal investigators Professor Jun Guo from Peking University Cancer Hospital and Professor Yiran Huang from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. This multicenter study, conducted across 47 medical centers, marked a significant advancement in immunotherapy for advanced RCC in China.

The study enrolled 421 randomized patients with medium to high-risk unresectable or metastatic RCC, assigning them randomly to receive either toripalimab in combination with axitinib or sunitinib alone. The primary endpoint was progression-free survival (PFS) as assessed by the Independent Review Committee (IRC), along with secondary endpoints including objective response rate (ORR), duration of response (DoR), disease control rate (DCR), overall survival (OS), and safety profile.

Previous presentations of the RENOTORCH study at the European Society for Medical Oncology (ESMO) congress 2023 demonstrated promising results. Toripalimab in combination with axitinib significantly prolonged PFS and showed higher ORR and longer DoR compared to sunitinib monotherapy, with a favorable safety profile.

Professors Jun Guo and Yiran Huang emphasized the significance of this approval in addressing unmet clinical needs for RCC patients in China, particularly those with medium to high risk. Dr. Jianjun Zou, Global Research and Development President of Junshi Biosciences, expressed gratitude to all stakeholders involved in the study and reaffirmed the company's commitment to advancing cancer care.

Toripalimab, an anti-PD-1 monoclonal antibody, has been the focus of numerous clinical studies globally and has demonstrated efficacy across multiple indications. Its approval for RCC in China marks a significant milestone in the treatment landscape for this disease.

 

Source: globenewswire.com

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