Tislelizumab plus chemotherapy as fi rst-line treatment of locally advanced or metastatic nonsquamous non-small-cell lung cancer (final analysis of RATIONALE-304: a randomized phase III trial)

被引：8

作者：

Lu, S. ^{[1
,11
]}

Wang, J. ^{[2
]}

Yu, Y. ^{[3
]}

Yu, X. ^{[4
]}

Hu, Y. ^{[5
]}

Ma, Z. ^{[6
]}

Li, X. ^{[7
]}

He, W. ^{[8
]}

Bao, Y. ^{[9
]}

Wang, M. ^{[10
]}

机构：

[1] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Sch Med, Dept Oncol, Shanghai, Peoples R China

[2] Chinese Acad Med Sci, Canc Hosp, Dept Med Oncol, Beijing, Peoples R China

[3] Harbin Med Univ, Canc Hosp, Dept Thorac Oncol, Harbin, Peoples R China

[4] Zhejiang Canc Hosp, Dept Thorac Oncol, Hangzhou, Peoples R China

[5] Hubei Canc Hosp, Dept Thorac Oncol, Wuhan, Peoples R China

[6] Henan Canc Hosp, Dept Med Oncol, Zhengzhou, Peoples R China

[7] Zhengzhou Univ, Affiliated Hosp 1, Henan Canc Hosp, Dept Med Oncol, Zhengzhou, Peoples R China

[8] BeiGene Beijing Co Ltd, Beijing, Peoples R China

[9] BeiGene Shanghai Co Ltd, Shanghai, Peoples R China

[10] Peking Union Med Coll, Peking Union Med Coll Hosp, Beijing 100730, Peoples R China

[11] Shanghai Jiao Tong Univ, 241 Huaihai West Rd, Shanghai 20030, Peoples R China

来源：

ESMO OPEN | 2024年 / 9卷 / 10期

基金：

国家重点研发计划; 中国国家自然科学基金;

关键词：

anti-PD-1; antibody; non-small-cell lung cancer; fi rst line; stage IIIB-IV; tislelizumab; 1ST-LINE TREATMENT; OPEN-LABEL; NSCLC; NIVOLUMAB; DOCETAXEL; PEMBROLIZUMAB; ATEZOLIZUMAB; MULTICENTER; PLATINUM;

D O I：

10.1016/j.esmoop.2024.103728

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The purpose of this study was to report an updated, fi nal analysis with longer follow-up for the open-label phase III RATIONALE-304 study of fi rst-line tislelizumab plus chemotherapy versus chemotherapy alone for advanced nonsquamous non-small-cell lung cancer (nsq-NSCLC). Materials and methods: Patients with histologically confirmed stage IIIB/IV nsq-NSCLC were randomized (2 : 1) to 4-6 cycles of tislelizumab plus platinum-based chemotherapy and pemetrexed every 3 weeks, followed by maintenance tislelizumab and pemetrexed, or platinum-based chemotherapy and pemetrexed alone every 3 weeks followed by maintenance pemetrexed. The primary endpoint was independent review committee (IRC)-assessed progression-free survival (PFSIRC). Overall survival (OS), safety, and tolerability were secondary endpoints. Results: Overall, 334 patients were randomized (tislelizumab plus chemotherapy: n = 223; chemotherapy: n = 111). At fi nal analysis (median follow-up 16.1 months), safety/tolerability profiles in both arms were consistent with the interim analysis. Tislelizumab plus chemotherapy continued to demonstrate prolongation of PFSIRC versus chemotherapy alone {stratified hazard ratio (HR) 0.63 [95% confidence interval (CI) 0.47-0.86]; median PFSIRC 9.8 months (95% CI 8.9-11.7 months) versus 7.6 months (95% CI 5.6-8.0 months), respectively}. OS stratified HR for tislelizumab plus chemotherapy versus chemotherapy was 0.90 (95% CI 0.63-1.28), with median OS of 21.4 months (95% CI 17.7 months-not estimable) versus 21.3 months (95% CI 15.6 months-not estimable), respectively. At a subsequent ad hoc analysis (median followup 19.3 months), OS HR between arms was 0.85 (95% CI 0.63-1.14); when adjusted for crossover using the two-stage method, the OS HR was 0.68 (95% CI 0.48-0.96). Conclusions: After longer follow-up, fi rst-line tislelizumab plus chemotherapy continued to demonstrate a manageable safety profile and a favorable PFS benefit over chemotherapy alone in patients with advanced/metastatic nsq-NSCLC.

引用

页数：10

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