Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

Summary

This study was designed to compare the efficacy and safety of tislelizumab (BGB-A317) combined with gemcitabine plus cisplatin versus placebo combined with gemcitabine plus cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal cancer.

Timeline

Start

2019-03-27

Primary completion

2021-03-26

Completion

2023-12-08

Outcome

Met primary endpoint

paper At interim analysis, progression-free survival (PFS) was significantly longer with tislelizumab-chemotherapy versus placebo-chemotherapy (hazard ratio: 0.52; 95% confidence interval: 0.38, 0.73; p < 0.0001). PMID 37207654 ↗

Publications

• Background Zhang L, Liu T, Wang H, Shi S, Yang Y. A Phase 3 Trial in Progress Comparing Tislelizumab Plus Chemotherapy With Placebo Plus Chemotherapy in Chinese Patients With Recurrent or Metastatic Nasopharyngeal Cancer. Abstract published at: 22nd Annual Meeting of the Chinese Society of Clinical Oncology; September, 2019; Xiamen, China.
• Yang Y, Yen CJ, Pan J, Wang H, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Wu Y, Yuan S, Chen C, Xu X, Ma X, Leaw S, Zhang L, Fang W. First-Line Tislelizumab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer: Three-Year Follow-Up of the Phase 3 RATIONALE-309 Randomized Clinical Trial. JAMA Oncol. 2026 Apr 1;12(4):384-393. doi: 10.1001/jamaoncol.2026.0020.
• Yang Y, Pan J, Chen N, Guo Y, Huang X, Wu Y, Leaw S, Bai F, Wang Y, Zhao N, Tang B, Barnes G. Effects of tislelizumab on health-related quality of life in patients with recurrent or metastatic nasopharyngeal cancer. Head Neck. 2024 Sep;46(9):2301-2314. doi: 10.1002/hed.27785. Epub 2024 Apr 26.
• Yang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Yu Q, Wang S, Wang G, Lei F, Wen J, Yang K, Lin Z, Guo Y, Chen S, Huang X, Wu Y, Liang L, Chen C, Bai F, Ma X, Zhang Y, Leaw S, Zhang L, Fang W. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023 Jun 12;41(6):1061-1072.e4. doi: 10.1016/j.ccell.2023.04.014. Epub 2023 May 18.

Drugs

Indications