HERTHENA-Lung01: A Phase II Study of Patritumab Deruxtecan (HER3-DXd) in Previously Treated Metastatic <i>EGFR</i> -mutated NSCLC
Helena A. Yu, James Chih‐Hsin Yang, Hidetoshi Hayashi, Yasushi Goto, Enriqueta Felip, Martin Reck, Michele Vigliotti, Qian Dong, F. Cantero, Pang‐Dian Fan, Masayuki Kanai, David Sternberg, Pasi A. Jänne
Abstract
Limited treatment options exist for EGFR-mutated NSCLC that has progressed after EGFR TKI and platinum-based chemotherapy. HER3 is highly expressed in EGFR-mutated NSCLC, and its expression is associated with poor prognosis in some patients. Patritumab deruxtecan (HER3-DXd) is an investigational, potential first-in-class, HER3-directed antibody–drug conjugate consisting of a HER3 antibody attached to a topoisomerase I inhibitor payload via a tetrapeptide-based cleavable linker. In an ongoing phase I study, HER3-DXd demonstrated promising antitumor activity and a tolerable safety profile in patients with EGFR-mutated NSCLC, with or without identified EGFR TKI resistance mechanisms, providing proof of concept of HER3-DXd. HERTHENA-Lung01 is a global, registrational, phase II trial further evaluating HER3-DXd in previously treated advanced EGFR-mutated NSCLC. Clinical Trial Registration: NCT04619004 (ClinicalTrials.gov); 2020-000730-17 (EudraCT)