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Proffered Paper session 2 - Genitourinary tumours, non-prostate

1882O - RENOTORCH: Toripalimab combined with axitinib versus sunitinib in first-line treatment of advanced renal-cell carcinoma (RCC) - A randomized, open-label, phase III study

Date

21 Oct 2023

Session

Proffered Paper session 2 - Genitourinary tumours, non-prostate

Topics

Tumour Immunology

Tumour Site

Renal Cell Cancer

Presenters

Xinan Sheng

Citation

Annals of Oncology (2023) 34 (suppl_2): S1013-S1031. 10.1016/S0923-7534(23)01924-5

Authors

X. Sheng1, M. Ye2, Q. Zou3, P. chen4, Z. He5, B. Wu6, D. He7, C. He8, X. Xue9, Z. Ji10, H. Chen11, S. Zhang12, Y. Liu13, W. Zhai14, X. Zhang15, C. Fu16, D. Xu17, M. Qiu18, Y. Huang14, J. Guo1

Author affiliations

  • 1 Urological Oncology Department, Peking University Cancer Hospital and Institute, 100142 - Beijing/CN
  • 2 Urology Surgery, Hunan Cancer Hospital, 410013 - Changsha/CN
  • 3 Urology Surgery, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 4 Urology, Affiliated Tumor Hospital of Xinjiang Medical University, 830000 - Urumqi/CN
  • 5 Urology, Peking University First Hospital, 100034 - Beijing/CN
  • 6 Urology, Shengjing Hospital of China Medical University - Nanhu Campus, 100004 - Shenyang/CN
  • 7 Urology Surgery, First Affiliated of Xian Communication University, 710061 - Xian/CN
  • 8 Urology, Henan Cacer Hospital, 450000 - Zhengzhou/CN
  • 9 Urology Surgery, The First Affiliated Hospital of Fujian Medical University, 350005 - Fuzhou/CN
  • 10 Urology, Chinese Academy of Medical Sciences and Peking Union Medical College - National Cancer Center, Cancer Hospital, 100021 - Beijing/CN
  • 11 Urology, Harbin Medical University Cancer Hospital, 150081 - Harbin/CN
  • 12 Department Of Biological Therapy, West China School of Medicine/West China Hospital of Sichuan University, 610041 - Chengdu/CN
  • 13 Oncology, The First Hospital of China Medical University, 110001 - Shenyang/CN
  • 14 Urology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 200127 - Shanghai/CN
  • 15 Urology Surgery, Beijing Chaoyang Hospital - Capital Medical University, 100020 - Beijing/CN
  • 16 Urology, Liaoning Cancer Hospital & Institute, 110042 - Shenyang/CN
  • 17 Urology, Ruijin Hospital - Shanghai Jiao Tong University School of Medicine, 200025 - Shanghai/CN
  • 18 Urology, Sichuan Academy of Medical Sciences/Sichuan Provincial People's Hospital, 610072 - Chengdu/CN

Resources

This content is available to ESMO members and event participants.

Abstract 1882O

Background

Anti-PD-1 antibody plus antiangiogenic therapy can play a synergistic antitumor role in the treatment of advanced renal cancer. Toripalimab is a humanized monoclonal antibody against PD-1. Here, we report the results of a randomized, open label, phase 3 trial (NCT04394975) comparing toripalimab plus axitinib with sunitinib as first-line treatment for advanced RCC patients (pts).

Methods

Eligible pts had untreated unresectable or metastatic clear cell RCC and were intermediate or poor risk per International Metastatic Renal Cell Carcinoma Database Consortium criteria. Pts were randomized in a 1:1 ratio to receive toripalimab (240mg) intravenously once every 3 weeks plus axitinib (5mg) orally twice daily or sunitinib (50mg) orally once daily for 4 weeks (6-week cycle) or 2 weeks (3-week cycle). The primary endpoint was progression-free survival (PFS) assessed by the blinded independent central review per RECIST version 1.1.

Results

A total of 421 pts were randomized: 210 to the toripalimab plus axitinib arm and 211 to the sunitinib arm. After a median follow-up of 14.6 months, a significant improvement in median PFS was detected for the toripalimab plus axitinib arm compared to the sunitinib arm (18.0 vs. 9.8 months, HR = 0.66 [95% CI: 0.49-0.87], P = 0.0034). The 1-year PFS rates were 62.5% and 45.4%, respectively. The objective response rate (ORR) was 56.7% (95% CI: 49.7-63.5) for the toripalimab plus axitinib arm versus 30.8% (95% CI: 24.6-37.5) for the sunitinib arm (P< 0.0001). The median overall survival was not reached in the toripalimab plus axitinib arm and 26.8 months in the sunitinib arm (HR = 0.61 [95% CI: 0.40-0.92], P = 0.0186). The incidence of Grade ≥ 3 adverse events (AEs) (71.2% vs 67.1%), AEs leading to discontinuation of treatment (14.4% vs 8.1%), and fatal AEs (1.0% vs 1.0%) were similar between two arms.

Conclusions

Among patients with previously untreated advanced RCC, treatment with toripalimab plus axitinib resulted in significantly longer PFS, as well as a higher ORR, than treatment with sunitinib. These results support the use of toripalimab with axitinib as a first-line treatment for advanced RCC.

Clinical trial identification

NCT04394975.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai Junshi Biosciences.

Funding

Shanghai Junshi Biosciences.

Disclosure

All authors have declared no conflicts of interest.

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