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Apalutamide in non-metastatic castration-resistant prostate cancer: a profile of its use

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Abstract

Apalutamide (ERLEADA®), a next-generation androgen receptor (AR) inhibitor, is approved in several countries, including those of the EU and in the USA, for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal SPARTAN study in men with nmCRPC who were at high risk of developing metastases despite androgen-deprivation therapy (+ ADT), oral apalutamide (+ ADT) significantly prolonged metastasis-free survival (MFS) compared with placebo (+ ADT) at a median follow-up of 20.3 months, with consistent benefits demonstrated across prespecified subgroups. At this timepoint, apalutamide (+ ADT) also significantly prolonged the time to metastasis and progression-free survival (PFS) and maintained health-related quality of life (HR-QOL) compared with placebo (+ ADT). Apalutamide is generally well tolerated, with most adverse reactions of mild to moderate severity and relatively few patients discontinuing treatment because of these events. Although mature OS results are awaited with interest, given its beneficial effects on MFS and convenient oral once-daily regimen, apalutamide (+ ADT) is an important emerging treatment option for patients with nmCRPC who are at high risk of developing metastatic disease.

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Acknowledgements

The manuscript was updated from Drugs 2019;79(14):1591–8 [7], and was reviewed by: U. Emmenegger, Sunnybrook Odette Cancer Centre, Medical Oncology, Toronto, ON, Canada; A. Pinto, University Hospital La Paz, Medical Oncology, Madrid, Spain. During the peer review process, Janssen-Cilag Ltd., the marketing-authorization holder of apalutamide, was offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Lesley J. Scott.

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The preparation of this review was not supported by any external funding.

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Lesley Scott is a salaried employee of Adis International Ltd./Springer Nature, is responsible for the article content and declares no conflicts of interest.

Additional information

Enhanced material for this Adis Drug Q&A can be found at https://doi.org/10.6084/m9.figshare.11301911.

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Scott, L.J. Apalutamide in non-metastatic castration-resistant prostate cancer: a profile of its use. Drugs Ther Perspect 36, 97–105 (2020). https://doi.org/10.1007/s40267-020-00707-z

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