Efficacy and Safety of Zongertinib in Previously Treated and Treatment-Naïve HER2-Mutant NSCLC from Beamion LUNG-1 Trial

EP: 1.Value of Comprehensive Molecular Testing in NSCLC

EP: 2.Unmet Needs in HER2-Mutant NSCLC

EP: 3.Treatment of HER2-Mutant NSCLC: Consequences of Delays and Strategies to Improve Timely Initiation

EP: 4.Overview of HER2-Targeted Therapies in NSCLC

EP: 5.Mechanistic Role of Emerging Tyrosine Kinase Inhibitors (TKIs) in HER2-Mutant NSCLC

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EP: 6.Efficacy and Safety of Zongertinib in Previously Treated and Treatment-Naïve HER2-Mutant NSCLC from Beamion LUNG-1 Trial

This episode reviews clinical findings on the efficacy and safety of zongertinib for HER2-mutant non-small cell lung cancer (NSCLC) as presented in the Beamion LUNG-1 trial. For previously treated patients, the trial demonstrated a high objective response rate of approximately 71% and a median progression-free survival of 12.4 months, with durable responses exceeding one year. Zongertinib also offered continued benefit for individuals who had received prior HER2-targeted therapies, although response rates were somewhat lower in these subgroups. In patients with non-kinase domain HER2 mutations, clinical activity was present but less pronounced. Among treatment-naive participants, recently presented data showed a 77% overall response rate and an 80% six-month progression-free survival, suggesting efficacy that compares favorably with conventional first-line therapies. The discussion notes that these results position zongertinib as a potentially transformative option for HER2-mutant NSCLC, with final placement in therapy awaiting further confirmation from ongoing phase 3 trials.