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

IF 48.8 1区医学 Q1 CELL BIOLOGY Cancer Cell Pub Date : 2024-01-04 DOI:10.1016/j.ccell.2023.12.004

Caicun Zhou, Yanping Hu, Ekaterine Arkania, Saadettin Kilickap, Kejing Ying, Fei Xu, Lin Wu, Xiang Wang, Maksym Viguro, Tamta Makharadze, Hongmei Sun, Feng Luo, Jianhua Shi, Aimin Zang, Yueyin Pan, Zhendong Chen, Zhongyao Jia, Vladimer Kuchava, Ping Lu, Ling Zhang, Jun Zhu

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Abstract

Combining immunotherapy with chemotherapy can provide improved survival in advanced squamous non-small-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 ≥3 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.

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serplulimab 加化疗作为晚期鳞状非小细胞肺癌一线治疗的全球 3 期研究（ASTRUM-004）

对于无靶向基因改变的晚期鳞状非小细胞肺癌（NSCLC）患者来说，将免疫疗法与化疗相结合可提高生存率。537名既往未接受过治疗的IIIB/IIIC或IV期无靶向基因改变的鳞状非小细胞肺癌患者被纳入研究，并随机（2:1）接受4.5 mg/kg的serplulimab或安慰剂治疗，两种药物均与纳布-紫杉醇和卡铂联合使用，静脉滴注，3周为一个周期。在第一次中期分析中，无进展生存期（PFS）这一主要终点已经达到。在第二次中期分析中，Serplulimab化疗组的无进展生存期获益得以维持（危险比[HR]0.53，95%置信区间[CI]0.42-0.67）。在最终分析中，与安慰剂化疗组相比，serplulimab化疗组显著改善了中位OS（HR 0.73，95% CI 0.58-0.93；P = 0.010）。分别有126例（35.2%）和58例（32.4%）患者发生了≥3级的丝普利单抗或安慰剂相关不良事件。我们的研究结果表明，在化疗中加入舍普利单抗可显著提高晚期鳞状NSCLC患者的生存率，且安全性可控。

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来源期刊

Cancer Cell 医学-肿瘤学

CiteScore

55.20

自引率

1.20%

发文量

179

审稿时长

4-8 weeks

期刊介绍： Cancer Cell is a journal that focuses on promoting major advances in cancer research and oncology. The primary criteria for considering manuscripts are as follows: Major advances: Manuscripts should provide significant advancements in answering important questions related to naturally occurring cancers. Translational research: The journal welcomes translational research, which involves the application of basic scientific findings to human health and clinical practice. Clinical investigations: Cancer Cell is interested in publishing clinical investigations that contribute to establishing new paradigms in the treatment, diagnosis, or prevention of cancers. Insights into cancer biology: The journal values clinical investigations that provide important insights into cancer biology beyond what has been revealed by preclinical studies. Mechanism-based proof-of-principle studies: Cancer Cell encourages the publication of mechanism-based proof-of-principle clinical studies, which demonstrate the feasibility of a specific therapeutic approach or diagnostic test.