Zongertinib Delivers Robust Efficacy in Previously Treated HER2-Mutant NSCLC

In a phase 1a-1b multicohort trial, zongertinib, an oral, irreversible, HER2-selective tyrosine kinase inhibitor (TKI), demonstrated impressive activity in patients with previously treated HER2-mutant NSCLC. In cohort 1 (tyrosine kinase domain mutations), a 71% confirmed objective response rate was achieved at the 120 mg dose with a median progression-free survival of 12.4 months and a median duration of response of 14.1 months. Safety data across cohorts were favorable, with few grade 3 or higher adverse events and no drug-related interstitial lung disease.

These results position zongertinib as a promising targeted therapy for HER2-mutant NSCLC, offering significant clinical benefit and a manageable safety profile for patients with limited treatment options.