Overview

• The FDA approved zongertinib for adults with unresectable or metastatic nonsquamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy.
• The phase 1 Beamion LUNG-1 trial reported a 71% objective response rate and 6-month progression-free survival and duration-of-response rates of 69% and 73%, respectively.
• Treatment-related adverse events were mostly grade 1 or 2, chiefly diarrhea (51%) and rash (27%), with dose reductions in 5%, discontinuations in 3%, and no reported interstitial lung disease.
• The FDA also approved the Oncomine DX Target Test as a companion diagnostic to identify eligible patients with HER2 exon 20 insertion mutations.
• Enrollment has begun in the randomized phase 3 Beamion LUNG-2 trial to compare zongertinib with standard-of-care therapy in HER2-mutant nonsquamous NSCLC.