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  1. Home
  3. First-line Zongertinib In Advanced Her2-mutant Non-small-cell Lung Cancer.
  1. Home
  3. First-line Zongertinib In Advanced Her2-mutant Non-small-cell Lung Cancer.

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First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.

John V Heymach1, Noboru Yamamoto2, Nicolas Girard3,4

  • 1Department of Thoracic/Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston.

The New England Journal of Medicine
|April 15, 2026

View abstract on PubMed

Summary
This summary is machine-generated.

Zongertinib demonstrates significant efficacy in previously untreated patients with HER2-mutant NSCLC, showing a 76% objective response rate. Treatment-related adverse events were mostly low-grade, indicating a favorable safety profile for this targeted therapy.

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Targeted therapy options for HER2-mutant non-small-cell lung cancer (NSCLC) were previously limited.
  • Zongertinib is a novel oral tyrosine kinase inhibitor designed to selectively target HER2 while sparing wild-type EGFR.

Purpose of the Study:

  • To evaluate the efficacy and safety of zongertinib in patients with advanced or metastatic HER2-mutant NSCLC.
  • To assess zongertinib's activity in patients with active brain metastases.

Main Methods:

  • A phase 1a-1b multicohort trial was conducted, focusing on zongertinib at 120 mg daily.
  • Primary endpoint was objective response rate; secondary endpoints included duration of response and progression-free survival.
  • Exploratory cohort assessed patients with active brain metastases.

Main Results:

  • In previously untreated patients (n=74), the objective response rate was 76% (95% CI, 65-84), with a median progression-free survival of 14.4 months.
  • In patients with brain metastases (n=30), the intracranial objective response rate was 47% (95% CI, 30-64).
  • Treatment-related adverse events were predominantly low-grade, with 19% of patients experiencing grade 3 or higher events.

Conclusions:

  • Zongertinib exhibits sustained efficacy in first-line treatment of HER2-mutant NSCLC.
  • The drug was generally well-tolerated, with manageable adverse events.
  • Zongertinib shows promise for patients with HER2-mutant NSCLC, including those with brain metastases.