Overview

• The FDA approved zongertinib (Hernexeos) for adult patients with unresectable or metastatic nonsquamous NSCLC harboring HER2 tyrosine kinase domain–activating mutations after prior systemic therapy.
• Beamion LUNG-1 Phase 1b data showed a 75% objective response rate in patients who had received platinum chemotherapy but no prior HER2 TKI or ADC, with 58% of responders maintaining their benefit for at least six months.
• Among those previously treated with both platinum chemotherapy and a HER2-targeted antibody-drug conjugate, zongertinib achieved a 44% response rate and a 27% rate of responses lasting six months or longer.
• Treatment-related adverse events were generally manageable—primarily diarrhea, hepatotoxicity and rash—with a discontinuation rate of only 2.9%.
• Continued approval depends on confirmatory trial results, and the randomized Phase 3 Beamion LUNG-2 study is underway to establish long-term efficacy and optimal clinical sequencing.