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Toripalimab plus axitinib approved in China for renal cell carcinoma

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The approval is based on findings from the phase 3 RENOTORCH trial, which showed that toripalimab plus axitinib prolonged progression-free survival and improved the objective response rate in patients with advanced RCC compared with sunitinib.

China’s National Medical Products Administration has approved a supplemental new drug application (sNDA) for toripalimab (Loqtorzi; Touyi) in combination with axitinib (Inlyta) for the first-line treatment of patients with medium- to high-risk unresectable or metastatic renal cell carcinoma (RCC), making it the first approved immunotherapy for RCC in China, announced Junshi Biosciences in a news release.1

At a median follow-up of 14.6 months, the median PFS in the toripalimab plus axitinib arm was 18.0 months, compared with 9.8 months in the sunitinib arm.

At a median follow-up of 14.6 months, the median PFS in the toripalimab plus axitinib arm was 18.0 months, compared with 9.8 months in the sunitinib arm.

“From a global perspective, targeted therapy in combination with immunotherapy has become the standard treatment approach for advanced RCC. However, no such treatments 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,” said Jun Guo, MD, PhD, in the news release.1 Guo is a professor and medical director of the department of melanoma and renal cancer at Peking University Cancer Hospital in Beijing, China.

The approval of the sNDA for toripalimab plus axitinib is supported by findings from the phase 3 RENOTORCH trial (NCT04394975), which were presented at the 2023 European Society of Medical Oncology (ESMO) Congress in Madrid, Spain and concurrently published in Annals of Oncology,2 the official journal of ESMO.

Overall, data from the trial showed that treatment with the combination of toripalimab plus axitinib prolonged progression-free survival (PFS) and improved the objective response rate (ORR) in patients with previously untreated advanced RCC compared with treatment with sunitinib (Sutent).

At a median follow-up of 14.6 months, the median PFS in the toripalimab plus axitinib arm was 18.0 months, compared with 9.8 months in the sunitinib arm (HR, 0.66; 95% CI, 0.49-0.87; P = .0034). At 1 year, the PFS rate among patients who had received toripalimab plus axitinib was 62.5%, vs 45.4% among patients who received sunitinib.

Further, the ORR among patients in the combination arm was 56.7% (95% CI, 49.7-63.5) compared with 30.8% (95% CI, 24.6-37.5) among patients in the sunitinib arm (P< .0001). At the time of data collection, the median duration of response (DoR) in the combination arm was not reached and was 16.7 months in the sunitinib arm (HR, 0.61). Additionally, the median overall survival (OS) had not been reached in the toripalimab plus axitinib cohort, compared with 26.8 months in the sunitinib cohort (HR, 0.61; 95% CI, 0.40-0.92; P = .0186).

Regarding safety, 71.2% of patients in the combination arm experienced an adverse event (AEs) of grade 3 or higher vs 67.1% of patients in the sunitinib arm. AEs led to treatment discontinuation in 14.4% and 8.1% of patients in each arm, respectively. Fatal AEs occurred in 1.0% of patients in each arm.

In total, the phase 3 RENOTORCH study enrolled 421 patients with RCC who were randomly assigned 1:1 to receive toripalimab plus axitinib (n = 210) or to sunitinib (n = 211). Patients were given 240 mg toripalimab intravenously once every 3 weeks plus 5 mg axitinib orally twice daily or 50 mg sunitinib orally once daily for 4 weeks on a 6-week cycle, or for 2 weeks on a 3-week cycle.

The primary end point for the study was PFS, as assessed by an Independent Review Committee. Secondary end points included ORR, DoR, OS, and safety.

With the approval of toripalimab in RCC, the drug is now currently approved in China under 8 different indications, including for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have failed prior platinum-based chemotherapy or have progressed within 12 months on neoadjuvant or adjuvant platinum-based chemotherapy.1

Yiran Huang, a professor at Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, concluded in the news release,1 “The treatment methods for advanced RCC are limited, especially for medium- to high-risk patients, who often face suboptimal prognoses. 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.”

References

1. Junshi Biosciences announces approval of the sNDA for toripalimab for the 1st-line treatment of renal cancer. News release. Junshi Biosciences. April 7, 2024. Accessed April 11, 2024. https://www.junshipharma.com/en/junshi-biosciences-announces-approval-of-the-snda-for-toripalimab-for-the-1st-line-treatment-of-renal-cancer/

2. Yan XQ, Ye MJ, Zou Q, et al. Toripalimab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma: RENOTORCH, a randomized, open-label, phase III study. Ann Oncol. 2024 Feb;35(2):190-199. doi:10.1016/j.annonc.2023.09.3108

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