Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

Long‑term overall survival follow-up of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (146366)

H-Q Mai 1 , Q Y Chen 1 , D Chen 2 , C Hu 3 , K Yang 4 , J Wen 5 , J Li 6 , Y Shi 7 , F Jin 8 , R Xu 9 , J Pan 10 , S Qu 11 , P Li 12 , C Hu 13 , Y C Liu 14 , Y Jiang 15 , X He 16 , H M Wang 17 , D W-T Lim 18 , Paul Smart 19 , R-H Xu 20
  1. Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, China
  2. Radiation Oncology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China
  3. Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
  4. Oncology Department, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology/ Cancer Center Union Hospital, Wuhan, China
  5. Oncology, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China
  6. Oncology, Jiangxi Provincial Cancer Hospital, Nanchang, China
  7. Department II of Head and Neck Radiotherapy, Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China
  8. Oncology, Guizhou Cancer Hospital of Guizhou Medical University, Guiyang, China
  9. Oncology, Shenzhen People's Hospital, Shenzhen, China
  10. Oncology, Fujian Cancer Hospital and Fujian Medical University Cancer Hospital, Fuzhou, China
  11. Oncology, The Peoples Hospital of Guangxi Zhuang Autonomous Region, Nanning, China
  12. Oncology, West China Hospital of Sichuan University, Chengdu, China
  13. Oncology, The Second Xiangya Hospital of Central South University, Changsha, China
  14. Radiation Oncology, Taichung Veterans General Hospital, Taichung City, Taiwan
  15. Oncology, Cancer Hospital of Shantou University Medical College, Shantou, China
  16. Oncology, Jiangsu Cancer Hospital,, Nanjing, China
  17. Oncology, Chang Gung Medical Foundation - Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan
  18. Medical Oncology Department, NCCS - National Cancer Centre Singapore, Singapore
  19. Dr Reddys Laboratories Australia, Sydney, NSW, Australia
  20. Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China

Aims

To report the long‑term overall survival outcomes of toripalimab combined with gemcitabine/cisplatin as first‑line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC), and to assess the impact of post‑progression immunotherapy on survival.

Methods

In the phase III JUPITER‑02 study (NCT03581786), adults with recurrent or metastatic NPC were randomised 1:1 to receive toripalimab 240 mg or placebo in combination with gemcitabine/cisplatin every three weeks for up to six cycles, followed by maintenance toripalimab or placebo until progression, unacceptable toxicity, or a maximum of two years. Stratification factors included Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) and disease status (recurrent vs primary metastatic).

The primary endpoint was progression‑free survival assessed by independent review; overall survival (OS) was a secondary endpoint. Sensitivity analyses adjusted for post‑progression programmed cell death protein‑1/programmed death ligand‑1 (PD‑1/PD‑L1) therapy using inverse probability of censoring weighting and two‑stage modelling.

Results

At the June 24, 2025, data cut‑off, 156 deaths had occurred. Median OS was 64.8 months in the toripalimab arm versus 33.7 months in the placebo arm (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.45–0.85). Among patients experiencing progression, 43% received subsequent immunotherapy. Sensitivity analyses adjusting for post‑progression PD‑1/PD‑L1 therapy demonstrated an improved HR of 0.52 (95% CI 0.38–0.72), median OS of 61.0 months versus 25.1 months in the toripalimab and placebo arms respectively. Findings indicate that subsequent immunotherapy contributed favourably to survival in the placebo arm but did not account for the substantial OS benefit observed with toripalimab.

Conclusions

Toripalimab plus gemcitabine/cisplatin provides a clinically meaningful and durable overall survival benefit compared with chemotherapy alone in recurrent or metastatic NPC, with a 31‑month improvement in median OS. Adjusted analyses support the robustness of the survival advantage, reinforcing toripalimab plus gemcitabine/cisplatin as a new standard of care first-line treatment option for advanced NPC.