Bob T Li, Funda Meric-Bernstam, Aditya Bardia, Yoichi Naito, Salvatore Siena, Philippe Aftimos, Ian Anderson, Giuseppe Curigliano, Maria de Miguel, Maitri Kalra, Do-Youn Oh, Joon Oh Park, Sophie Postel-Vinay, Sun Young Rha, Taroh Satoh, Iben Spanggaard, Flavia Michelini, Ann Smith, Karime Kalil Machado, Cristina Saura
BACKGROUND: Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate approved by the US Food and Drug Administration and the European Medicines Agency for HER2-mutant non-small-cell lung cancer. Few treatment options exist for patients with HER2-mutant solid tumours beyond lung cancers. We investigated trastuzumab deruxtecan in metastatic solid tumours with specific activating HER2 mutations. METHODS: In this open-label, phase 2, basket study done in 29 centres in Asia, Europe, and North America, we investigated trastuzumab deruxtecan (5·4 mg/kg every 3 weeks by intravenous infusion) in patients aged 18 years or older with unresectable or metastatic solid tumours with specific activating HER2 mutations, an Eastern Cooperative Oncology Group performance status of 0 or 1, and disease progression following previous treatment (previous HER2-targeted therapy was permitted) or with no satisfactory alternative treatment options...
May 3, 2024: Lancet Oncology