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Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309)

Open access
Yang, Yunpeng, Pan, Jianji, Wang, Hui, Zhao, Yuanyuan, Qu, Shenhong, Chen, Nianyong, Chen, Xiaozhong, Sun, Yan, He, Xiaohui, Hu, Chaosu, Lin, Lizhu, Yu, Qitao, Wang, Siyang, Wang, Guihua, Lei, Feng, Wen, Jiyu, Yang, Kunyu, Lin, Zhixiong, Guo, Ye, Chen, Shaoqing, Huang, Xiaoming, Wu, Yanjie, Liang, Liang, Chen, Chenqi, Bai, Fan, Ma, Xiaopeng, Zhang, Yun, Leaw, Shiangjiin, Zhang, Li, Fang, Wenfeng·2023·Cancer Cell

Abstract

Checkpoint inhibitors are effective in recurrent/metastatic nasopharyngeal cancer (R/M NPC). RATIONALE-309 (NCT03924986) randomized 263 treatment-naive R/M NPC patients to tislelizumab or placebo every 3 weeks (Q3W), plus chemotherapy (Q3W for 4-6 cycles). 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). PFS benefit for tislelizumab-chemotherapy versus placebo-chemotherapy was observed regardless of programmed death-ligand 1 expression. PFS after next line of treatment and overall survival showed favorable trends for tislelizumab-chemotherapy versus placebo-chemotherapy. The safety profile was similar between arms. Gene expression profiling (GEP) identified immunologically "hot" tumors, and showed an activated dendritic cell (DC) signature was associated with tislelizumab-chemotherapy PFS benefit. Our results support that tislelizumab-chemotherapy should be considered as first-line treatment for R/M NPC, and GEP and activated DC signature results may help identify patients who might benefit most from immunochemotherapy treatment. VIDEO ABSTRACT.

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Metadata

Authors
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.
Venue
Cancer Cell
Publisher
Elsevier BV
Published
2023-06
Volume
41
Issue
6
Pages
1061-1072.e4
ISSN
1535-6108 (ISSN-L)
OpenAlex
W4377020104
Cited by
237
References
2
FWCI
52.00
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). https://app.cochat.ai/papers/10.1016/j.ccell.2023.04.014
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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., . . . Fang, W. (2023). Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. https://doi.org/10.1016/j.ccell.2023.04.014

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.