Pneumologie 2025; 79(S 01): S48
DOI: 10.1055/s-0045-1804642
Abstracts
B1 – Pneumologische Onkologie

Primary Phase Ib Analysis of Beamion LUNG-1: Zongertinib (BI 1810631) in Patients with HER2 Mutation-Positive NSCLC

Authors

  • G Ruiter

    1   Netherlands Cancer Institute

  • H Tu

    2   Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences)

  • M Ahn

    3   Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea; Cois: Advisory Board Participation for Bms, Ariad and Lilly.

  • K Yoh

    4   National Cancer Center Hospital East

  • J Zugazagoitia

    5   12 de Octubre Hospital

  • E Smit

    6   Netherlands Cancer Institute, Leiden University Medical Center

  • Y Wu

    7   Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences; Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences)

  • D Planchard

    8   Institut Gustave Roussy, Thoracic Group and International Center for Thoracic Cancers

  • B Cho

    9   Yonsei Cancer Center, Yonsei University College of Medicine,; Division of Medical Oncology,

  • B Wehler

    10   Universitätsklinikum Gießen Marburg GmbH Standort Gießen, Medizinische Klinik Iv/V

  • Y Zhao

    11   The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

  • T Wehler

    12   Universitätsklinikum Gießen und Marburg GmbH

  • U von Wangenheim

    13   Boehringer Ingelheim Pharma GmbH & Co. Kg

  • M Rohrbacher

    14   Boehringer Ingelheim International GmbH

  • B Sadrolhefazi

    15   Boehringer Ingelheim Pharmaceuticals, Inc.

  • G Lin

    16   Fujian Cancer Hospital

  • Y Yu

    17   Harbin Medical University Cancer Hospital

  • E Nadal

    18   Catalan Institute of Oncology, L'hospitalet

  • J Heymach

    19   MD Anderson Cancer Center, University of Texas
Further Information
Also available at
 
 

    Introduction: Zongertinib is a novel, orally administered HER2-specific TKI that binds selectively and covalently to the HER2-TKD, sparing WT EGFR and limiting EGFR-related AEs. In Nov 2023, zongertinib was granted Fast Track Designation (US FDA) as an invest. treatment (Tx) for pts with adv/met HER2 mutation-pos. (m+) NSCLC who had PD on/after platinum-based therapy. Beamion LUNG-1 is an ongoing, Ph Ia/Ib, first-in-human, open-label study, evaluating the safety and efficacy of zongertinib in pts with HER2 aberration-pos. (abr+) solid tumors (Ph Ia) and HER2m+NSCLC (Ph Ib). In Ph Ia (May 2024 cut-off), zongertinib conferred confirmed ORR/DCR of 32.3/87.9% in pts with pretreated HER2abr+solid tumors (all dose levels), and 35.8/94.3% in pts with HER2m+NSCLC, with few manageable EGFR-related AEs. MTD was NR; doses in dose optimization were 120/240 mg QD. Here, we report results from Ph Ib Cohort 1.

    Methods: Ph Ib is recruiting pts with HER2m+adv/met NSCLC into 5 cohorts: 1. pre-treated HER2 TKDm+; 2. Tx-naïve HER2 TKDm+; 3. pre-treated non-TKD HER2m+; 4. active BMs; and 5. prior Tx with anti-HER2 ADC. Cohort 1: initial randomization to 120 (selected at interim analysis)/240 mg zongertinib QD; prim. endpoint: OR by BICR, sec. endpoints: DoR and PFS.

    Results: As of May 2024, 132 pts have been treated in Ph Ib Cohort 1 with zongertinib at 120 mg/240 mg QD (n=75/57). 57.6% were female; median age at BL was 62 years (range: 30-82). Further results are summarized in [Fig. 1]:

    Zoom
    Fig. 1  

    Conclusions: Z was well tolerated and demonstrated promising efficacy in pts with HER2m+NSCLC; the prim endpoint of Beamion LUNG-1 Ph Ib Cohort 1 was met.


     

    Publication History

    Article published online:
    18 March 2025

    © 2025. Thieme. All rights reserved.

    Georg Thieme Verlag KG
    Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

     
    Zoom
    Fig. 1