期刊
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
卷 149, 期 3, 页码 1357-1360出版社
SPRINGER
DOI: 10.1007/s00432-022-04412-4
关键词
Biomarker; Immunotherapy; PD-L1; Oncology drug approval; Health Policy
类别
The current indications for pembrolizumab are complex and may not capture all potential responders. Using pembrolizumab in any metastatic solid tumor may lead to better outcomes, considering the heterogeneity of response to checkpoint inhibitors and limited predictive biomarkers.
The current approval indications for pembrolizumab are complex, reflecting the inclusion criteria of numerous clinical trials that led to approvals. Here we argue that allowing the use of pembrolizumab to any advanced solid tumor in any tumor type in any line of therapy for a fixed duration may be preferable to the current assortment of indications. The aggregate response rate in landmark clinical trials for approved indications of pembrolizumab is low and even lower in real-world populations. Due to heterogeneity of response to checkpoint inhibitors and limited predictive biomarkers, there are subsets of patients without approved indications for pembrolizumab that may have response to checkpoint inhibitors. The current regulatory framework of numerous overlapping clinical trials leading to complex approval indications is redundant and inefficient. We conclude that giving pembrolizumab in any metastatic solid tumor in any setting may lead to better outcomes with minimal increase in cost. Randomized clinical trials should focus more on optimal duration of treatment based on tumor type and initial response to checkpoint inhibitors.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据