Histology-agnostic approvals for antibody-drug conjugates in solid tumours: is the time ripe?

Corti, Chiara; Antonarelli, Gabriele; Valenza, Carmine; Nicolo, Eleonora; Rugo, Hope; Cortes, Javier; Harbeck, Nadia; Carey, Lisa A.; Criscitiello, Carmen und Curigliano, Giuseppe (2022): Histology-agnostic approvals for antibody-drug conjugates in solid tumours: is the time ripe? In: European Journal of Cancer, Bd. 171: S. 25-42

Abstract

Several antibody-drug conjugates (ADCs) have been recently approved to treat solid tumours. Since ADCs seem to have activity in multiple malignancies sharing the expression of a specific antigen, they may be mirroring the experience of histology-agnostic-targeted treatments. So, the possibility to interpret the activity of some ADCs across different cancer types in a biomarker-driven perspective arises. However, relevant biological, methodological, and regulatory challenges should be highlighted and addressed, in order to grant ADCs biomarker-driven regulatory approvals in the next future. In this review, we discuss challenges and opportunities posed by the pan-histological expansion of ADCs in solid tumours. In particular, we provide an overview about technological and manufacturing advancements;we offer up-to-date highlights of the current evidence from clinical trials investigating ADCs in solid tumours;we discuss the need for the identification of optimal predictive biomarkers, as well as major methodological, statistical, and regulatory considerations for a biomarker-driven histology-agnostic approach. (C) 2022 Elsevier Ltd. All rights reserved.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0959-8049
• Sprache: Englisch