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ARAMIS final OS and nmCRPC safety outcomes

Prof. Karim Fizazi, Institut Gustave Roussy, France
ASCO 2020
Phase 3, ARAMIS
The final 3-year overall survival (OS) results for the ARAMIS trial (darolutamide vs placebo) in non-metastatic castration-resistant prostate cancer (nmCRPC) were positive. A head-to-head analysis of safety comparing darolutamide with apalutamide and enzalutamide data from other trials showed that for the general safety outcomes, there were no statistically significant differences after matching, although darolutamide showed an advantage for some specific adverse events. ARAMIS was a randomised, double-blind, placebo-controlled, phase 3 trial in men with nmCRPC and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned to receive darolutamide (300 mg tablets twice daily) or placebo while continuing androgen-deprivation therapy. The primary endpoin...

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