Skip to main content
AMCP Nexus 2025 Posters Main banner

    Oncology

    E-Poster Available

    (301) Zongertinib in patients with pretreated human epidermal growth factor receptor 2-mutant advanced non–small cell lung cancer: Beamion LUNG-1

    Wednesday, October 29, 2025

      Primary Author(s)

    • John Heymach, MD, PhD

      Chair of Thoracic/Head and Neck Medical Oncology
      Division of Cancer Medicine, University of Texas MD Anderson Cancer Center
      Huston, Texas, United States

      • Co-Author(s)

    • Gerrina Ruiter, MD, PhD

      Pulmonologist
      Department of Clinical Pharmacology, Department of Thoracic Oncology, Netherlands Cancer Institute
      Amsterdam, Noord-Holland, Netherlands

    • Myung-Ju Ahn, MD, PhD

      Professor of Hematology-Oncology
      Samsung Medical Center, Sungkyunkwan University School of Medicine
      Seoul, Inch'on-jikhalsi, Republic of Korea

    • Nicolas Girard, MD, PhD

      Head of Medical Oncology Department
      Institut Curie, Institut du Thorax Curie-Montsouris
      Paris, Ile-de-France, France

    • Egbert Smit, MD, PhD

      Professor of Pulmonary Medicine
      Department of Pulmonary Diseases, Leiden University Medical Center
      Leiden, Noord-Holland, Netherlands

    • David Planchard, MD, PhD

      Head of Thoracic Group
      Department of Medical Oncology, Institut Gustave Roussy, Thoracic Group and International Centre for Thoracic Cancers
      Villejuif, Franche-Comte, France

    • Yi-Long Wu, n/a

      Chief Physician
      Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China
      Guangzhou, Guangdong, China (People's Republic)

    • Byoung Chul Cho, MD, PhD

      Professor of Internal Medicine
      Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine
      Seoul, Inch'on-jikhalsi, Republic of Korea

    • Noboru Yamamoto, MD, PhD

      Deputy Director for Research
      Department of Experimental Therapeutics, National Cancer Center Hospital
      Tokyo, Tokyo, Japan

    • Joshua Sabari, MD

      Thoracic Oncologist
      Division of Medical Oncology, Perlmutter Cancer Center, New York University Langone Health
      New York City, New York, United States

    • Yanqiu Zhao, MD

      Director of Department of Medical Oncology
      The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
      Zhengzhou, Henan, China (People's Republic)

    • Hai-Yan Tu, MD

      Associate Professor
      Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
      Guangzhou, Guangdong, China (People's Republic)

    • Kiyotaka Yoh, MD

      Assistant Chief of Thoracic Oncology
      Department of Thoracic Oncology, National Cancer Center Hospital East
      Chiba, Chiba, Japan

    • Ernest Nadal, MD, PhD

      Head of Section of Thoracic Tumors
      Thoracic Tumors Unit, Medical Oncology, Catalan Institute of Oncology (ICO), Bellvitge Biomedical Research institute (IDIBELL), L'Hospitalet
      Barcelona, Catalonia, Spain

    • Behbood Sadrolhefazi, MD

      Director, Clinical Program Leader/Oncology
      Boehringer Ingelheim Pharmaceuticals, Inc.
      Ridgefield, Connecticut, United States

    • Maren Rohrbacher, MD, PhD

      Lead Patient Safety Physician
      Boehringer Ingelheim International GmbH
      Rheinland-Pfalz, Rheinland-Pfalz, Germany

    • Ute von Wangenheim, MD, PhD

      Principal Statistician
      Boehringer Ingelheim International GmbH
      Rheinland-Pfalz, Rheinland-Pfalz, Germany

      • Presenter(s)

    • Ute von Wangenheim, MD, PhD

      Principal Statistician
      Boehringer Ingelheim International GmbH
      Rheinland-Pfalz, Rheinland-Pfalz, Germany

      • Co-Author(s)

    • Sabina Eigenbrod-Giese, MD, PhD, MBA

      Senior Clinical Program Lead
      Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
      Ingelheim am Rhein, Rheinland-Pfalz, Germany

    • Jon Zugazagoitia, MD, PhD

      Attending Physician-Scientist in Medical Oncology
      Department of Medical Oncology, 12 de Octubre Hospital
      Madrid, Madrid, Spain


    Background:     : Zongertinib is an irreversible tyrosine kinase inhibitor that selectively inhibits HER2 while sparing EGFR, thereby limiting associated toxicities. Beamion LUNG-1 (NCT04886804) is a Phase (Ph) Ia/Ib study evaluating zongertinib in patients (pts) with HER2-mutant advanced/metastatic non-small cell lung cancer (NSCLC) in Ph Ib. At primary analysis (May 2024) of Ph Ib Cohort (C) 1, the primary endpoint, confirmed response by blinded independent central review (BICR), was met in patients (pts) with pretreated HER2-mutant NSCLC within the tyrosine kinase domain (TKD).

    Objective: : To report the median duration of response (DoR) and median progression-free survival (PFS) for C1, and first data from C3 and C5.

    Methods: : In C1, pts with pretreated HER2-mutant NSCLC within the TKD were initially randomized to receive zongertinib 120 mg or 240 mg once-daily; the 120 mg dose was selected at an interim analysis. In exploratory C3, pts had pretreated HER2-mutant NSCLC with TKD or non-TKD mutations. In C5, pts had HER2-mutant NSCLC within the TKD and were pretreated with a HER2-directed antibody–drug conjugate. In C3 and C5, pts initially received zongertinib 240 mg. Once the 120 mg dose was selected in C1, all newly recruited pts received zongertinib 120 mg. Primary endpoint was objective response (best overall response of complete or partial response; RECIST v1.1) by BICR (C1 and C5) and investigator review (C3). Secondary endpoints included DoR and PFS.

    Results: : As of November 29, 2024, 75 pts in C1, 20 pts with non-TKD mutations in C3, and 31 pts in C5 had received zongertinib 120 mg; treatment was ongoing in 33 (44%), 4 (20%), and 13 (42%) pts, respectively. The objective response rate (ORR) by BICR and disease control rate (DCR) were 71% (95% CI: 60–80) and 96% (95% CI: 89–99) in C1, 30% (95% CI: 15–52) and 65% (95% CI: 43–82) in C3, and 48% (95% CI: 32–65) and 97% (95% CI: 84–99) in C5. Median (95% CI) DoR and PFS were 14.1 (6.9–not evaluable [NE]) months (m) and 12.4 (8.2–NE) m in C1 and 5.3 (2.8–NE) months and 6.8 (5.4–NE) months in C5. DoR and PFS in C3 were not yet mature. Drug-related adverse events (all/grade [G] ≥3) were reported in 97%/17%, 80%/25%, and 77%/3% of pts in C1, C3, and C5, respectively, most commonly diarrhea in all cohorts (mainly G1). There were no cases of drug-related interstitial lung disease.

    Conclusions: : Zongertinib demonstrated significant and clinically meaningful activity with a manageable safety profile in pts with pretreated advanced NSCLC harboring HER2 mutations.

    Sponsorship:: Boehringer Ingelheim