Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.

doi:10.1056/NEJMoa2511065

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Article

Sevabertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.

The New England journal of medicine - 6 Nov 2025

Le Xiuning, Kim Tae Min, Loong Herbert H, Prelaj Arsela, Goh Boon Cher, Li Lin, Fang Yong, Lu Shun, Dong Xiaorong, Wu Lin, Shinno Yuki, Daniele Gennaro, Yang Tsung-Ying, Kim Hye Ryun, Ruiter Gerrina, Zhao Jun, Novello Silvia, Miao Liyun, Jänne Pasi A, Goto Koichi, Rüttinger Dominik, Descamps Tine, Brase Jan Christoph, Bao Weichao, Li Rui, Brega Nicoletta, Grassi Paolo, Girard Nicolas, Tan Daniel Shao-Weng

Abstract excerpt

BACKGROUND: HER2 gene mutations occur in 2 to 4% of patients with non-small-cell lung cancer (NSCLC). Sevabertinib is an oral, reversible tyrosine kinase inhibitor that has shown anti-HER2 activity in preclinical models. METHODS: We conducted an open-label, multicenter, multicohort, phase 1-2 study to evaluate sevabertinib at a twice-daily dose of 20 mg in patients with locally advanced or metastatic HER2-mutant...

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PMID: 41104928
DOI: 10.1056/NEJMoa2511065

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