Apalutamide in non-metastatic castration-resistant prostate cancer: a profile of its use
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Funding: The preparation of this review was not supported by any external funding.
Conflicts of interest: 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 about this Adis Drug Review can be found here
(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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