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@ARTICLE{Heymach:309658,
      author       = {J. V. Heymach and S. Popat and E. F. Smit and P.
                      Christopoulos$^*$ and D. Planchard and T. Yoshida and J.
                      Zugazagoitia and Y. Yu and B. Wilding},
      title        = {{T}he role of zongertinib, a highly selective tyrosine
                      kinase inhibitor, in targeting {HER}2-mutant {NSCLC}: a
                      bench-to-bedside review.},
      journal      = {Expert review of anticancer therapy},
      volume       = {nn},
      issn         = {1473-7140},
      address      = {Abingdon, Oxon},
      publisher    = {Taylor $\&$ Francis},
      reportid     = {DKFZ-2026-00290},
      pages        = {nn},
      year         = {2026},
      note         = {#NCTZFB9# / epub},
      abstract     = {HER2 is mutated in $2-4\%$ of non-small cell lung cancers
                      (NSCLC) and is associated with poor prognosis. Tyrosine
                      kinase inhibitors (TKIs) targeting HER2 have historically
                      been hampered by insufficient efficacy against exon 20
                      insertion mutations and lack of specificity, resulting in
                      off-target adverse events. Zongertinib is an oral,
                      irreversible HER2-selective TKI that spares wild-type EGFR,
                      thereby minimizing associated toxicities. Zongertinib was
                      recently approved in the United States (accelerated), China
                      (conditional), and Japan for patients with previously
                      treated advanced HER2-mutant NSCLC.This article outlines the
                      discovery and clinical development of zongertinib that led
                      to these approvals. We discuss the first-in-human Beamion
                      LUNG-1 trial (NCT04886804), in which zongertinib
                      demonstrated encouraging and durable activity, with a
                      manageable safety profile, in patients with HER2-mutant
                      advanced NSCLC. Finally, we summarize ongoing clinical
                      trials of zongertinib, including its assessment as
                      first-line treatment for advanced HER2-mutant
                      NSCLC.Zongertinib is the first oral TKI approved for
                      HER2-mutant NSCLC and will provide patients with a
                      convenient, tolerable and effective treatment option in an
                      area of significant unmet need. Next steps include its
                      potential transition to a first-line setting, identification
                      of additional indications, and development of novel
                      combination regimens.},
      subtyp        = {Review Article},
      keywords     = {Zongertinib (Other) / human epidermal growth factor
                      receptor 2 (Other) / non-small cell lung cancer (Other) /
                      targeted therapy (Other) / tyrosine kinase inhibitor
                      (Other)},
      cin          = {HD02},
      ddc          = {610},
      cid          = {I:(DE-He78)HD02-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41640088},
      doi          = {10.1080/14737140.2026.2623059},
      url          = {https://inrepo02.dkfz.de/record/309658},
}