81P Safety and effectiveness of apalutamide for the treatment of non-metastatic castration-resistant prostate cancer (nm-CRPC): Preliminary results from an open-label expanded access protocol (EAP)

Abstract

Background: When apalutamide was not commercially available, expanded access protocols were key to providing treatment access and evidence generation. These preliminary results from EAP aims to describe safety and effectiveness of apalutamide plus androgen-deprivation therapy (ADT) for the treatment of nm-CRPC. Methods:This multicenter, open-label, EAP included patients 18 years with confirmed nm-CRPC. Participants received oral apalutamide 240 mg once daily plus ADT until disease progression, unacceptable toxicity, withdrawal of consent, study closure or death. Data on serious treatment-emergent adverse events (TEAEs), all grade 3 adverse events (AEs) and AEs of special interest were collected. The data were summarized using descriptive statistics, with median and range, as well as mean and standard deviation (SD).