Brant Simon Boge, Børø Siri, Jonasson Christian, Helland Åslaug, Thoresen Steinar
NordicRWE, Oslo, Norway.
Univeristy of Oslo, Oslo, Norway.
Clin Pharmacol Ther. 2025 Apr;117(4):1123-1130. doi: 10.1002/cpt.3591. Epub 2025 Feb 6.
The KEYNOTE-042 trial showed the benefit of treating patients with non-oncogene addicted advanced NSCLC with PD-L1 tumor proportion score over 50% with pembrolizumab as monotherapy over platinum-doublet chemotherapy. To contextualize these results, we undertake a detailed emulation of the inclusion criteria in KEYNOTE-042 using Norwegian health registry data and discuss both the clinical contexts, as well as the general utility of such registry data for pharmacoepidemiologic research in oncology. Within the population of patients with PD-L1 tumor proportion score over 50%, an observational analog of an intention-to-treat analysis showed similar results to those of the KEYNOTE-042 study.
KEYNOTE-042试验表明,对于非癌基因成瘾性晚期非小细胞肺癌患者,当程序性死亡配体1(PD-L1)肿瘤比例评分超过50%时,使用帕博利珠单抗单药治疗比铂类双联化疗更具优势。为了更好地理解这些结果,我们利用挪威健康登记数据对KEYNOTE-042的纳入标准进行了详细模拟,并讨论了临床背景以及此类登记数据在肿瘤药物流行病学研究中的一般用途。在PD-L1肿瘤比例评分超过50%的患者群体中,一项意向性治疗分析的观察性模拟结果与KEYNOTE-042研究的结果相似。