The Additional Exclusions of ROS1 Fusions (In Addition to EGFR Mutation and ALK Fusions) in the Cemiplimab NSCLC FDA Indication (EMPOWER-Lung 1and-Lung 3) . Catching Up with Current Scientific View of Immunotherapy in Never-Smoker Predominant Actionable Driver Mutation Positive NSCLC?

被引：6

作者：

Brazel, Danielle ^{[1
]}

Ou, Saihong Ignatius ^{[2
,3
]}

机构：

[1] Univ Calif Irvine, Dept Med, Sch Med, Orange, CA 92868 USA

[2] Chao Family Comprehens Canc Ctr, Orange, CA 92868 USA

[3] Univ Calif Irvine, Chao Family Comprehens Canc Ctr, Dept Med, Div Hematol Oncol,Sch Med, 200 South Manchester,Suite 400, Orange, CA 92868 USA

来源：

LUNG CANCER-TARGETS AND THERAPY | 2023年 / 14卷

关键词：

cemiplimab; immunotherapy; actionable driver mutation; ROS1; fusion; 1ST-LINE TREATMENT; OPEN-LABEL; CANCER; PEMBROLIZUMAB; PHASE-3; CHEMOTHERAPY;

D O I：

10.2147/LCTT.S413611

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Cemiplimab is one of seven immune checkpoint inhibitors (ICIs) approved for the first-line (1L) treatment of advanced NSCLC in the US based on EMPOWER-Lung 1 and-Lung 3 trials. In addition to exclusion of NSCLC patients harboring EGFR mutations and ALK fusion from 1L treatment with ICIs, exclusion of ROS1 fusion is an additional unique exclusion the use of criterion for cemiplimab in the US FDA indication based on the design of the EMPOWER lung trials. We review the effectiveness of ICIs in never-smoker predominant NSCLC with driver mutations (EGFR, ALK, ROS1, RET, HER2) and question whether exclusion of ROS1 fusion would put cemiplimab at a competitive disadvantage given the requirement for insurance to prove ROS1 fusion negativity. We further discuss whether the US FDA as a regulatory authority has the right and responsibility to harmonize the use of ICIs in these actionable driver mutations to standardize community practice for the benefit of patients and to advance the development of next -generation treatment for these driver mutations.

引用

页码：63 / 69

页数：7

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