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作为先进的非状非小细胞肺癌的第一线治疗,Prolgolimab与化疗一起使用

K Laktionov¹, A Smolin², D Stroyakovskiy³

¹FSBI "N.N. Blokhin National Medical Research Center of Oncology" of the Russian Ministry of Health, Moscow, Russia.

European journal of cancer (Oxford, England : 1990)

|January 29, 2025

概括

在标准化疗中添加prolgolimab显著改善了高级非小细胞肺癌患者的整体存活率和无进展存活率. 这种组合疗法显示出良好的安全性,包括PD-L1阴性病例.

科学领域:

免疫治疗是一种免疫疗法.
在瘤学瘤学.
临床试验临床试验

背景情况:

普罗戈利马布是一种IgG1抗PD-1单克隆抗体,具有Fc沉默突变.
在DOMAJOR研究中,研究了第一线高级非小细胞肺癌 (NSCLC) 的prolgolimab.

研究的目的:

评估prolgolimab与化疗相结合的疗效和安全性,与安慰剂加化疗相比.
评估总生存率 (OS) 和无进展生存率 (PFS) 作为主要终点.

主要方法:

292名患有晚期非状核细胞核癌的患者被随机分组.
治疗包括使用prolgolimab (3 mg/kg Q3W) 或安慰剂进行4次化疗,然后进行维持治疗.
患者接受治疗,直到疾病进展或毒性,长达36个月.

主要成果:

在prolgolimab组中没有达到中位数的生存期,而在安慰剂组中为14.6个月 (HR,0.51;p=0.0001).
预后活力持续时间中位数为7.7个月与prolgolimab和5.5个月与安慰剂 (HR,0.65;p=0.0004).
血型肌素增加和呼吸障碍是最常见的不良事件,没有新的安全问题.

结论:

在晚期NSCLC患者中,添加prolgolimab与化疗显著改善了OS和PFS.
无论PD-L1表达状态如何,都观察到生存益处.
组合治疗没有显示出新的安全问题.

关键词:

抗PD-1病毒的使用.非小细胞肺癌是非小细胞肺癌.在 PD-L1 表达式上.在很长一段时间内,可能会出现问题.

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