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24-11-2020 | Castration-resistant prostate cancer | Adis Journal Club | Article

Targeted Oncology

Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer

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Authors: Lesley J. Scott

Abstract

Oral darolutamide (Nubeqa™) is a novel second-generation, nonsteroidal, selective androgen receptor (AR) inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal multinational, phase 3 ARAMIS trial in men with nmCRPC, relative to placebo plus ongoing androgen deprivation therapy (ADT), darolutamide (+ ADT) significantly prolonged metastasis-free survival (MFS) at the time of the primary analysis and overall survival (OS) at the time of the final OS analysis and was generally well tolerated in extended follow-up. Albeit long-term data from the real-world setting are required to fully define the safety profile of darolutamide, current evidence from the final ARAMIS analysis indicates that darolutamide has a low propensity for CNS-related adverse events (AEs) associated with other currently approved second-generation AR inhibitors. Given the efficacy and safety evidence from the final ARAMIS analysis and the key role of second-generation AR inhibitors in the management of nmCRPC, darolutamide + ADT represents an important emerging option for the treatment of men with nmCRPC who are at high risk of developing metastatic prostate cancer.

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Darolutamide: clinical considerations in nmCRPC 

Second-generation AR inhibitor, with a distinct chemical structure relative to other anti-androgens

Low blood-brain barrier penetration; low potential for drug-drug interaction

Significantly prolongs MFS and OS vs placebo (+ ADT)

Generally well tolerated, with the nature and incidence of most AEs similar to those of placebo

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