China’s NMPA Accepts sNDA for Frontline Toripalimab Plus Axitinib in Metastatic RCC

China’s National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) seeking the approval of toripalimab (Tuoyi) plus axitinib (Inlyta) for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (RCC).¹

The sNDA is supported by data from an interim analysis of the phase 3 RENOTORCH trial (NCT04394975), which showed that the combination led to an improvement in progression-free survival (PFS) vs single-agent sunitinib (Sutent). An independent data monitoring committee determined that the study met its primary end point of PFS, as assessed by independent radiographic review (IRC) committee.²

“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,” Jianjun Zou, MD, PhD, president of Global Research and Development at Junshi Biosciences, stated in a news release. “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’ PFS. This means that the field of renal cancer treatment in China may soon welcome its very first ‘immune-targeting’ combination therapy.”

RENOTORCH was a multicenter, randomized, open-label, active-controlled trial that enrolled patients between 18 and 80 years of age with histologically confirmed, unresectable, recurrent or metastatic RCC with a clear cell component with or without sarcomatoid features who had not previously received systemic treatment.³ Other key inclusion criteria included an International Metastatic Database Consortium score of medium to high risk, at least 1 measurable disease lesion per RECIST v1.1 criteria, an ECOG performance status of 0 or 1, and acceptable organ function.

Patients were excluded if they received prior treatment with anti–PD-1, anti–PD-L1, or anti–CTLA-4 agents, experienced disease progression or recurrence during neoadjuvant/adjuvant therapy for RCC or within 12 months after the last dose of treatment, or had major surgery within 4 weeks of enrollment.

The study enrolled 421 patients who were randomly assigned 1:1 to receive 240 mg of intravenous toripalimab every 3 weeks plus 5 mg of oral axitinib twice daily, or 50 mg of oral sunitinib per day on a 4-weeks-on/2-weeks-off schedule or a 2-weeks-on/1-week-off schedule.

PFS by IRC served as the primary end point. Secondary end points consisted of investigator-assessed PFS, overall response rate by IRC or investigator assessment, duration of response, disease control rate, overall survival, and safety.

“We will actively communicate and collaborate with regulatory authorities and hope to soon provide more effective and accessible treatment options to Chinese patients,” Zou added.

References

1. Junshi Biosciences announces acceptance of the supplemental new drug application for toripalimab. News release. Shanghai Junshi Biosciences, Ltd. July 11, 2023. Accessed July 12, 2023. https://www.globenewswire.com/news-release/2023/07/12/2703193/0/en/Junshi-Biosciences-Announces-Acceptance-of-the-Supplemental-New-Drug-Application-for-Toripalimab.html
2. Junshi Biosciences announces primary endpoint met in RENOTORCH study of toripalimab for 1st-line treatment of advanced renal cell carcinoma. News release. Shanghai Junshi Biosciences, Ltd. April 27, 2023. Accessed July 12, 2023. https://www.junshipharma.com/en/4/2023
3. Study to evaluate the efficacy and safety of toripalimab in combination with axitinib versus sunitinib monotherapy in advanced renal cell cancer. ClinicalTrials.gov. Updated April 26, 2023. Accessed July 12, 2023. https://clinicaltrials.gov/ct2/show/NCT04394975