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.

Histology-agnostic approvals for antibody-drug conjugates in solid tumours: is the time ripe? / C. Corti, G. Antonarelli, C. Valenza, E. Nicolò, H. Rugo, J. Cortés, N. Harbeck, L.A. Carey, C. Criscitiello, G. Curigliano. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 1879-0852. - 171:(2022 Aug), pp. 25-42. [10.1016/j.ejca.2022.04.039]

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

C. Corti
Primo
;
G. Antonarelli
Secondo
;
C. Valenza;C. Criscitiello
Penultimo
;
G. Curigliano
Ultimo
2022

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.
ADC; Clinical trials; Drug development; Drug discovery; Histology-agnostic; Regulatory
Settore MED/06 - Oncologia Medica
ago-2022
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/985547
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