Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report

Introduction: Treatment options for HER2-mutant patients with non-small cell lung cancer (NSCLC) are limited. New agents, including zongertinib, a HER2-selective tyrosine kinase inhibitor (TKI), are being investigated in clinical trials. However, published clinical data on the efficacy and safety of...

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Main Authors: Oliver Illini, Anna Sophie Lang-Stöberl, Hannah Fabikan, Christoph Weinlinger, Arschang Valipour, Maximilian J. Hochmair
Format: Article
Language:English
Published: Elsevier 2024-01-01
Series:Cancer Treatment and Research Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2468294225000139
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author Oliver Illini
Anna Sophie Lang-Stöberl
Hannah Fabikan
Christoph Weinlinger
Arschang Valipour
Maximilian J. Hochmair
author_facet Oliver Illini
Anna Sophie Lang-Stöberl
Hannah Fabikan
Christoph Weinlinger
Arschang Valipour
Maximilian J. Hochmair
author_sort Oliver Illini
collection DOAJ
description Introduction: Treatment options for HER2-mutant patients with non-small cell lung cancer (NSCLC) are limited. New agents, including zongertinib, a HER2-selective tyrosine kinase inhibitor (TKI), are being investigated in clinical trials. However, published clinical data on the efficacy and safety of zongertinib are limited to data from a single phase I trial including only 36 patients with NSCLC. Methods: We report real-world data on six consecutive patients with HER2-mutant NSCLC who received zongertinib through a named patient use program between December 2023 and June 2024. Radiological response evaluation and blood testing were routinely performed every two to three months, and adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Results: All patients were diagnosed with a metastatic adenocarcinoma, had previously progressed on at least one line of chemotherapy and had been previously treated with trastuzumab-deruxtecan (two had to stop treatment because of pneumonitis). Three patients (50%) presented with an Eastern Cooperative Oncology Group (ECOG) performance status of ≥2. A clinical and radiological benefit was achieved in all patients (complete response (1), partial response (4), and stable disease (1)). In one patient with brain metastases, a complete response was achieved. Treatment with zongertinib is ongoing in all patients. Adverse events were reported in one patient (elevated blood pressure (grade 1). Conclusion: Zongertinib may be an effective and well-tolerated treatment option for HER2-mutant NSCLC patients even if they are heavily pretreated, have a reduced performance status or have a history of pneumonitis and brain metastases.
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spelling doaj-art-ebb5eea3c90b46f0843ad7af302287212025-02-09T05:00:48ZengElsevierCancer Treatment and Research Communications2468-29422024-01-0142100875Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief reportOliver Illini0Anna Sophie Lang-Stöberl1Hannah Fabikan2Christoph Weinlinger3Arschang Valipour4Maximilian J. Hochmair5Department of Respiratory and Critical Care Medicine, Clinic Floridsdorf, Vienna Healthcare Group, Bruenner Straße 68, Vienna 1210, Austria; Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, Austria; Corresponding author at: Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology Clinic Floridsdorf, Vienna Healthcare Group, Bruenner Straße 68, Vienna 1210, Austria.Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, AustriaKarl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, AustriaKarl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, AustriaDepartment of Respiratory and Critical Care Medicine, Clinic Floridsdorf, Vienna Healthcare Group, Bruenner Straße 68, Vienna 1210, Austria; Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, AustriaDepartment of Respiratory and Critical Care Medicine, Clinic Floridsdorf, Vienna Healthcare Group, Bruenner Straße 68, Vienna 1210, Austria; Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Clinic Floridsdorf, Bruenner Straße 68, Vienna 1210, AustriaIntroduction: Treatment options for HER2-mutant patients with non-small cell lung cancer (NSCLC) are limited. New agents, including zongertinib, a HER2-selective tyrosine kinase inhibitor (TKI), are being investigated in clinical trials. However, published clinical data on the efficacy and safety of zongertinib are limited to data from a single phase I trial including only 36 patients with NSCLC. Methods: We report real-world data on six consecutive patients with HER2-mutant NSCLC who received zongertinib through a named patient use program between December 2023 and June 2024. Radiological response evaluation and blood testing were routinely performed every two to three months, and adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5. Results: All patients were diagnosed with a metastatic adenocarcinoma, had previously progressed on at least one line of chemotherapy and had been previously treated with trastuzumab-deruxtecan (two had to stop treatment because of pneumonitis). Three patients (50%) presented with an Eastern Cooperative Oncology Group (ECOG) performance status of ≥2. A clinical and radiological benefit was achieved in all patients (complete response (1), partial response (4), and stable disease (1)). In one patient with brain metastases, a complete response was achieved. Treatment with zongertinib is ongoing in all patients. Adverse events were reported in one patient (elevated blood pressure (grade 1). Conclusion: Zongertinib may be an effective and well-tolerated treatment option for HER2-mutant NSCLC patients even if they are heavily pretreated, have a reduced performance status or have a history of pneumonitis and brain metastases.http://www.sciencedirect.com/science/article/pii/S2468294225000139ZongertinibBI 1810631HER 2 mutationHER 2 inhibitorsNon-small cell lung cancer
spellingShingle Oliver Illini
Anna Sophie Lang-Stöberl
Hannah Fabikan
Christoph Weinlinger
Arschang Valipour
Maximilian J. Hochmair
Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
Cancer Treatment and Research Communications
Zongertinib
BI 1810631
HER 2 mutation
HER 2 inhibitors
Non-small cell lung cancer
title Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
title_full Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
title_fullStr Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
title_full_unstemmed Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
title_short Very first real-world data on zongertinib use in non-small cell lung cancer patients with HER2 mutations: A brief report
title_sort very first real world data on zongertinib use in non small cell lung cancer patients with her2 mutations a brief report
topic Zongertinib
BI 1810631
HER 2 mutation
HER 2 inhibitors
Non-small cell lung cancer
url http://www.sciencedirect.com/science/article/pii/S2468294225000139
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