SHANGHAI, China, April 7, 2024 — 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 National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for toripalimab (product code: JS001) in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”). This is the first approved immunotherapy for renal carcinoma in China.
Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma. There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022. Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy. According to the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), the median overall survival (“OS”) of patients with low, medium and high risk metastatic RCC receiving anti-vascular targeted treatment were 35.3, 16.6 and 5.4 months, respectively. Therefore, compared to low-risk patients, the clinical needs for new treatment options are more urgent for patients with medium and high risk advanced RCC.
The approval of the sNDA is mainly based on data from the RENOTORCH study (NCT04394975), a multi-center, randomized, open-label, active-controlled Phase 3 clinical study 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. The study was conducted across 47 medical centers, and represents the first pivotal Phase 3 clinical study of immunotherapy for patients with advanced RCC in China.
A total of 421 randomized patients with medium to high risk unresectable or metastatic RCC were enrolled in the study and randomly assigned in a 1:1 ratio to receive toripalimab in combination with axitinib (n=210) or sunitinib alone (n=211). The primary endpoint is progression free survival (“PFS”) as assessed by the Independent Review Committee (“IRC”), and secondary endpoints include PFS as assessed by investigators, objective response rate (“ORR”) as assessed by IRC or investigators, duration of response (“DoR”), disease control rate (DCR), OS, safety profile, etc.
Previously, the study results of RENOTORCH made its debut at the Proffered Paper Session of the European Society for Medical Oncology (ESMO) congress 2023. The full text was simultaneously published in Annals of Oncology, the official journal of ESMO. The study data showed that, based on the assessment results of IRC, compared with sunitinib monotherapy, toripalimab in combination with axitinib for the treatment significantly prolonged the PFS of patients by nearly twofold (median PFS: 18.0 vs. 9.8 months, P=0.0028), and the risk of disease progression or death was reduced by 35% (hazard ratio [HR]=0.65; 95% CI: 0.49, 0.86). In addition, the ORR was higher (56.7% vs. 30.8%, P<0.0001) and the DoR was longer (median DoR: not reached vs 16.7 months; HR=0.61) in the toripalimab group. The OS of the toripalimab group also showed a clear trend of benefit (median OS: not reached vs 26.8 months), and the risk of death was reduced by 39% (HR=0.61; 95%CI: 0.40, 0.92). In terms of safety, toripalimab in combination with axitinib demonstrated a favorable safety and tolerability profile, and no new safety signals were observed.
“From a global perspective, targeted therapy in combination with immunotherapy has become the standard treatment approach for advanced RCC,” said Professor Jun GUO from Peking University Cancer Hospital. “However, no such treaments have been approved in China. The approval of toripalimab’s new indications opens a new chapter in combined targeted therapy and immunotherapy in China, and it will transform current clinical practices for advanced RCC and introduce new treatment options for medium to high-risk patients!”
“The treatment methods for advanced RCC are limited, especially for medium to high risk patients, who often face suboptimal prognoses,” said Professor Yiran HUANG from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China. Compared to targeted monotherapy, toripalimab combined with targeted therapy will significantly improve patients’ PFS, offering promising prospects for many advanced RCC patients in China.”
“Thank you to all medical professionals, patients, and R&D personnel involved in the RENOTORCH study for their contributions,” said Dr. Jianjun ZOU, CEO of Junshi Biosciences. “Their dedication has led to a pioneering breakthrough in renal cancer, first of its kind in China! Junshi Biosciences will remain committed to addressing domestic clinical needs and continue investing in research and development to help patients live longer and better!”