What is the role of apalutamide (Erleada) in the treatment of hormone-refractory prostate cancer?

Updated: Dec 29, 2020
  • Author: Martha K Terris, MD, FACS; Chief Editor: Edward David Kim, MD, FACS  more...
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Another androgen receptor–targeting therapy, apalutamide (Erleada), was approved in 2018 for use in nonmetastatic CRPC. The FDA based its new approval on safety and efficacy data from the phase 3 SPARTAN (Selective Prostate Androgen Receptor Targeting With ARN-509) trial. Median metastasis-free survival, which was the primary trial endpoint, was 40.5 months in the apalutamide group (n=806) as compared with 16.2 months in the placebo group (n=401). That translated into a 72% reduction in the relative risk for metastasis or death with apalutamide (HR, 0.28; 95% CI 0.23 - 0.35; P < 0.001). All participants also received hormone therapy, either gonadotropin-releasing hormone analogue therapy or surgical castration. [50]

Apalutamide was also approved for mCSPC in September 2019. Approval was based on the phase 3 TITAN trial (n = 1052)j, in which apalutamide plus ADT significantly extended overall survival compared with placebo plus ADT (HR=0.67; 95% CI, 0.51-0.89; P = 0.0053). Progression-free survival was also significantly improved in the apalutamide group (HR=0.48; 95% CI, 0.39-0.60; P< 0.0001). [51]

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