Multicenter phase 2 study of poziotinib for previously treated advanced NSCLC with HER2 exon 20 insertion mutations

Insertion mutations in HER2 exon 20 occur in 2%-5% of non-small cell lung cancers and function as oncogenic drivers. Poziotinib is a small molecule tyrosine kinase inhibitor. Cohort 2 of the multicenter phase 2 ZENTIH20 study evaluated poziotinib for previously treated advanced or metastatic NSCLC. The objective response rate was 27.8% (95% CI 18.9-38.2) and the disease control rate was 70.0% (59.4-79.2). Median duration of response was 5.1 months (95% CI 4.2-5.5) and the median progression-free survival was 5.5 months (3.9-5.8). The authors conclude that poziotinib is a potentially meaningful therapeutic option for patients with metastatic lung cancer harboring HER2 exon 20 insertion mutations.