A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

被引：11

作者：

Zhou, Caicun ^{[1
]}

Hu, Yanping

Arkania, Ekaterine ^{[3
]}

Kilickap, Saadettin ^{[4
,21
]}

Ying, Kejing ^{[5
]}

Xu, Fei ^{[6
]}

Wu, Lin ^{[7
]}

Wang, Xiang ^{[8
]}

Viguro, Maksym ^{[20
]}

Makharadze, Tamta ^{[3
]}

Sun, Hongmei ^{[9
]}

Luo, Feng ^{[10
]}

Shi, Jianhua ^{[11
]}

Zang, Aimin ^{[12
]}

Pan, Yueyin ^{[13
]}

Chen, Zhendong ^{[14
]}

Jia, Zhongyao ^{[15
]}

Kuchava, Vladimer ^{[16
]}

Lu, Ping ^{[17
]}

Zhang, Ling ^{[18
]}

Cheng, Ying ^{[19
]}

Kang, Wenying ^{[20
]}

Wang, Qingyu ^{[19
]}

Yu, Haoyu ^{[20
]}

Li, Jing ^{[1
,20
]}

Zhu, Jun ^{[20
]}

机构：

[1] Shanghai Pulm Hosp, Dept Med Oncol, Shanghai 200433, Peoples R China

[2] Hubei Canc Hosp, Dept Med Oncol, Wuhan 430000, Peoples R China

[3] LTD Israeli Georgian Med Res Clin Helsicore, GE-0112 Tbilisi, Georgia

[4] Hacettepe Univ, Fac Med, Dept Med Oncol, TR-06230 Ankara, Turkiye

[5] Zhejiang Univ, Sir Run Run Shaw Hosp, Sch Med, Dept Pneumol, Hangzhou 310016, Peoples R China

[6] Nanchang Univ, Affiliated Hosp 1, Dept Pneumol, Nanchang 330006, Peoples R China

[7] Cent South Univ, Hunan Canc Hosp, Affiliated Canc Hosp, Dept Thorac Med Oncol,Xiangya Sch Med, Changsha 410013, Peoples R China

[8] Xuzhou Cent Hosp, Dept Med Oncol, Xuzhou 221009, Peoples R China

[9] Jiamusi Tumor Hosp, Dept Med Oncol, Jiamusi 154007, Peoples R China

[10] Sichuan Univ, West China Hosp, Lung Canc Ctr, Chengdu 610041, Peoples R China

[11] Linyi Canc Hosp, Dept Med Oncol, Linyi 276000, Peoples R China

[12] Hebei Univ, Affiliated Hosp, Dept Med Oncol, Baoding 071000, Peoples R China

[13] Univ Sci & Technol China, Anhui Prov Hosp, Affiliated Hosp 1, Dept Med Oncol, Hefei 230001, Peoples R China

[14] Anhui Med Univ, Affiliated Hosp 2, Dept Med Oncol, Hefei 230601, Peoples R China

[15] Linyi Peoples Hosp, Dept Oncol, Linyi 276002, Peoples R China

[16] LTD Inst Clin Oncol, GE-0159 Tbilisi, Georgia

[17] Xinxiang Med Univ, Affiliated Hosp 1, Dept Oncol, Xinxiang 453100, Peoples R China

[18] Nanchang Univ, Affiliated Hosp 1, Dept Oncol, Nanchang 330006, Peoples R China

[19] Jilin Canc Hosp, Dept Oncol, Changchun 130012, Peoples R China

[20] Shanghai Henlius Biotech Inc, Shanghai 200233, Peoples R China

[21] Istinye Univ, Fac Med, Dept Med Oncol, TR-34010 Istanbul, Turkiye

来源：

CANCER CELL | 2024年 / 42卷 / 02期

关键词：

NAB-PACLITAXEL; GEMCITABINE; CARBOPLATIN; PLACEBO; TRIAL;

D O I：

10.1016/j.ccell.2023.12.004

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous nonsmall -cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3 -week cycles. The primary endpoint of progression -free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo -chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade R3 serplulimab or placebo -related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.

引用

页码：198 / 208.e3

页数：15

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