Zongertinib: A Promising Oral Targeted Therapy for Previously Treated HER2-Mutant Non–Small-Cell Lung Cancer

Highlights

• Zongertinib, an oral HER2-selective tyrosine kinase inhibitor, achieved a 71% objective response rate in previously treated HER2-mutant NSCLC patients with tyrosine kinase domain mutations.
• Median duration of response was 14.1 months, and median progression-free survival was 12.4 months in the primary cohort.
• The safety profile was manageable, with mostly low-grade adverse events and no drug-related interstitial lung disease observed.
• Zongertinib demonstrated activity even in patients previously treated with HER2-directed antibody–drug conjugates and those with non–tyrosine kinase domain mutations.

Clinical Background and Disease Burden