Spotlight on Patritumab Deruxtecan (HER3-DXd) from HERTHENA Lung01. Is a Median PFS of 5.5 Months Enough in Light of FLAURA-2 and MARIPOSA?

IF 5.1 Q1 ONCOLOGY
Lung Cancer: Targets and Therapy Pub Date : 2024-07-09 eCollection Date: 2024-01-01 DOI:10.2147/LCTT.S467169
Zhaohui Liao Arter, Misako Nagasaka
{"title":"Spotlight on Patritumab Deruxtecan (HER3-DXd) from HERTHENA Lung01. Is a Median PFS of 5.5 Months Enough in Light of FLAURA-2 and MARIPOSA?","authors":"Zhaohui Liao Arter, Misako Nagasaka","doi":"10.2147/LCTT.S467169","DOIUrl":null,"url":null,"abstract":"<p><p>On December 22, 2023, the US Food and Drug Administration (FDA) approved the biologics license application for patritumab deruxtecan (HER3-DXd) for priority review. This treatment is aimed at adult patients with locally advanced or metastatic NSCLC with EGFR mutations, who have received at least two prior systemic therapies. Approval of patritumab deruxtecan would mark it as the first HER3 targeted therapy in the United States. This prioritization by the FDA is grounded in compelling results from the global Phase II HERTHENA-Lung01 trial, wherein HER3-DXd exhibited clinically meaningful efficacy, achieving a median progression-free survival (mPFS) of 5.5 months in patients with heavily treated EGFR-mutated NSCLC. A pivotal question remains: Is a mPFS of 5.5 months sufficient in the context of the evolving first-line landscape observed in the FLAURA-2 and MARIPOSA trials?</p>","PeriodicalId":18066,"journal":{"name":"Lung Cancer: Targets and Therapy","volume":null,"pages":null},"PeriodicalIF":5.1000,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247161/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung Cancer: Targets and Therapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/LCTT.S467169","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

On December 22, 2023, the US Food and Drug Administration (FDA) approved the biologics license application for patritumab deruxtecan (HER3-DXd) for priority review. This treatment is aimed at adult patients with locally advanced or metastatic NSCLC with EGFR mutations, who have received at least two prior systemic therapies. Approval of patritumab deruxtecan would mark it as the first HER3 targeted therapy in the United States. This prioritization by the FDA is grounded in compelling results from the global Phase II HERTHENA-Lung01 trial, wherein HER3-DXd exhibited clinically meaningful efficacy, achieving a median progression-free survival (mPFS) of 5.5 months in patients with heavily treated EGFR-mutated NSCLC. A pivotal question remains: Is a mPFS of 5.5 months sufficient in the context of the evolving first-line landscape observed in the FLAURA-2 and MARIPOSA trials?

聚焦 HERTHENA Lung01 中的帕妥珠单抗德鲁司坦(HER3-DXd)。考虑到 FLAURA-2 和 MARIPOSA,5.5 个月的中位 PFS 是否足够?
2023 年 12 月 22 日,美国食品和药物管理局(FDA)批准了帕妥珠单抗-德鲁司康(HER3-DXd)的生物制品许可申请,进行优先审评。该疗法主要针对表皮生长因子受体(EGFR)突变的局部晚期或转移性非小细胞肺癌成年患者,这些患者之前至少接受过两种系统疗法。帕妥珠单抗-德鲁司坦的批准将标志着它成为美国首个HER3靶向疗法。HER3-DXd表现出了有临床意义的疗效,在接受过大量治疗的表皮生长因子受体(EGFR)突变NSCLC患者中,中位无进展生存期(mPFS)达到了5.5个月。一个关键问题依然存在:在FLAURA-2和MARIPOSA试验中观察到的一线治疗形势不断变化的背景下,5.5个月的中位无进展生存期是否足够?
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
8.10
自引率
0.00%
发文量
10
审稿时长
16 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信