HERTHENA-Lung01: a phase II study of patritumab deruxtecan (HER3-DXd) in previously treated metastatic EGFR-mutated NSCLC.

This article describes a clinical trial of a new drug to treat non-small-cell lung cancer. About a third of patients with non-small-cell lung cancer have tumors with changes (mutations) in a gene called EGFR, which cause tumors to grow. These patients are treated with EGFR inhibitors and chemotherapy, both of which can stop the tumor from growing for a period of time. When these treatments stop working, new and effective treatments are needed. Most non-small-cell lung cancer tumors have a protein called HER3 on the surface of their cells. Patritumab deruxtecan (HER3-DXd) is a new drug candidate that uses HER3 to get chemotherapy inside tumor cells. In an earlier clinical trial for patients with lung cancer whose disease had grown after multiple treatments, HER3-DXd often shrank tumors or stopped them from growing. The side effects of HER3-DXd were tolerable. The clinical trial described in this publication, HERTHENA-Lung01 (NCT04619004), is testing HER3-DXd in a larger group of patients with non-small-cell lung cancer that has activating mutations in the EGFR gene and for whom previous treatments have stopped working. The results of this study will help doctors and regulators decide if HER3-DXd should be approved and used for patients with non-small-cell lung cancer with EGFR mutations.