New oral drug shows high efficacy in HER2-mutated lung cancer

  • The targeted inhibitor ‘Zongertinib’ obtains positive responses in more than 70% of patients treated with this drug.
Nadal NOTI 2

A new oral drug called Zongertinib has achieved very promising results in the treatment of patients with non-small cell lung cancer (NSCLC) with mutations in the HER2 gene, a type of tumour that is difficult to treat, especially when patients have already received other treatments without any success. These results are derived from an international Phase 1 study, published in the New England Journal of Medicine, in which Ernest Nadal, director of Research and Innovation, head of the Preclinical and Experimental Research of Thoracic Tumors group at IDIBELL, and medical oncologist specialized in lung cancer at the Catalan Institute of Oncology (ICO) has participated, and which has been presented at the congress of the American Association for Cancer Research (AACR) held this week in the city of Chicago (USA).

This treatment is specifically designed to target HER2 mutations, a genetic alteration found in a small percentage of lung tumors (between 1.8% and 4%). Unlike other therapeutic options, which are usually administered intravenously and can cause some serious side effects, this new oral drug has shown a much more favourable and practical safety profile for patients.

 

A one-pill-a-day treatment with promising results

The study, called “Beamion LUNG-1”, has included more than 120 patients distributed in various groups according to the type of mutation and previous treatments, and has shown promising results. The group that has obtained the best results has been that of patients with a specific mutation within the tyrosine kinase domain, where 71% of those who have taken the drug have shown a significant reduction of the tumour, with very few side effects and an average of one year free of disease before the tumour reappears.

On the other hand, in patients who had already received an antibody directed against HER2, as well as in other less common mutations, good responses have also been observed (between 30% and 48%). In addition to its efficacy, the drug stands out for its safety since only 17% of the patients treated have suffered serious adverse effects related to the treatment, and there wasn’t any case of serious inflammation of the lung caused by the treatment.

For the medical oncologist specialising in lung and one of the researchers who participated in the study, Ernest Nadal, “We are facing an important advance, because this new treatment, zongertinib, has shown high efficacy for a specific subgroup of patients with lung cancer with a mutation of the HER2 gene. Compared to other treatments that had been studied in this subgroup of patients, zongertinib has several advantages for being an oral therapy, due to good tolerance and because it does not cause lung inflammation.”

The research team that has prepared this study continues in this line of research in order to confirm these results in a phase III trial, which seeks to demonstrate whether this targeted therapy is more beneficial than chemo-immunotherapy as the first treatment in this defined population of patients. At this point, and if these results are maintained, zongertinib could become a new tool in the treatment of HER2-mutated lung cancer and, above all, for a group of patients who until now had few treatment alternatives.

 

 

The Bellvitge Biomedical Research Institute (IDIBELL) is a research center established in 2004 specialized in cancer, neuroscience, translational medicine, and regenerative medicine. It counts on a team of more than 1.500 professionals who, from 73 research groups, publish more than 1.400 scientific articles per year. IDIBELL is participated by the Bellvitge University Hospital and the Viladecans Hospital of the Catalan Institute of Health, the Catalan Institute of Oncology, the University of Barcelona, ​​and the City Council of L’Hospitalet de Llobregat.

IDIBELL is a member of the Campus of International Excellence of the University of Barcelona HUBc and is part of the CERCA institution of the Generalitat de Catalunya. In 2009 it became one of the first five Spanish research centers accredited as a health research institute by the Carlos III Health Institute. In addition, it is part of the “HR Excellence in Research” program of the European Union and is a member of EATRIS and REGIC. Since 2018, IDIBELL has been an Accredited Center of the AECC Scientific Foundation (FCAECC).

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Original source: John V. Heymach et al. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. The New England Journal of Medicine. 2025.

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