Arter Zhaohui Liao, Nagasaka Misako
Division of Hematology/Oncology, University of California Irvine School of Medicine, Orange, CA, USA.
Chao Family Comprehensive Cancer Center, Orange, CA, USA.
Lung Cancer (Auckl). 2024 Jul 9;15:115-121. doi: 10.2147/LCTT.S467169. eCollection 2024.
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?
2023年12月22日，美国食品药品监督管理局（FDA）批准了帕妥珠单抗德曲妥珠单抗（HER3-DXd）的生物制品许可申请，进行优先审评。该疗法针对患有表皮生长因子受体（EGFR）突变的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者，这些患者此前至少接受过两种全身治疗。帕妥珠单抗德曲妥珠单抗的获批将使其成为美国首个HER3靶向疗法。FDA的这一优先审评基于全球II期HERTHENA-Lung01试验的令人信服的结果，在该试验中，HER3-DXd显示出具有临床意义的疗效，在接受过大量治疗的EGFR突变NSCLC患者中，中位无进展生存期（mPFS）达到5.5个月。一个关键问题仍然存在：在FLAURA-2和MARIPOSA试验中观察到的不断演变的一线治疗格局背景下，5.5个月的mPFS是否足够？
