Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): A first-in-human, multicentre, phase 1–2 trial
The Lancet Oncology Feb 14, 2019
de Bono JS, et al. - In a mixed population of patients with locally advanced or metastatic (or both) solid tumours known to express tissue factor, researchers tested tisotumab vedotin (a first-in-human antibody–drug conjugate directed against tissue factor) with respect to its safety, tolerability, pharmacokinetic profile, and antitumour activity in a phase 1–2, open-label, dose-escalation and dose-expansion study done at 21 centres in the USA and Europe (InnovaTV 201). Eligible patients were those aged ≥18 years, had relapsed, advanced, or metastatic cancer of the ovary, cervix, endometrium, bladder, prostate, oesophagus, squamous cell carcinoma of the head and neck or non-small-cell lung cancer; an Eastern Cooperative Oncology Group performance status of 0–1; and had relapsed after or were not eligible to receive the available standard of care. Findings revealed a manageable safety profile of tisotumab vedotin, with epistaxis (102 [69%] of 147 patients), fatigue (82 [56%]), nausea (77 [52%]) etc. reported as the most common (in ≥20% of patients) treatment-emergent adverse events of any grade. Furthermore, tisotumab vedotin displayed encouraging preliminary antitumour activity across multiple tumour types in heavily pretreated patients.
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