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

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.

• Authors: Chiara Corti, Gabriele Antonarelli, Carmine Valenza, Eleonora Nicolò, Hope Rugo, Javier Cortés, Nadia Harbeck, Lisa A Carey, Carmen Criscitiello, Giuseppe Curigliano
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 171 Pg. 25-42 (08 2022) ISSN: 1879-0852 [Electronic] England
• PMID: 35696887 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2022 Elsevier Ltd. All rights reserved.

Chemical References

• Antineoplastic Agents
• Biomarkers
• Immunoconjugates

Topics

• Antineoplastic Agents (therapeutic use)
• Biomarkers
• Humans
• Immunoconjugates (therapeutic use)
• Neoplasms (therapy)