5 ARAMIS Trial Findings Metastasis-Free Survival (MFS) After a median follow-up of 17.9 months, darolutamide plus ADT demonstrated a statistically signicant improvement in MFS of 40.4 months [95% CI 34.33 – NR] vs 18.4 months [95% CI 15.51 – 22.34] in the placebo plus ADT arm and reduced the risk of metastasis or death by 59% compared to placebo [HR .41 (95% CI 0.34 – 0.50); P <0.001]. This improvement in MFS (Figure 2) was consistent among patients irrespective of baseline characteristics, therapy and demographics. See 3 Table 3 and Figure 1. 1,3 Figure 2. ARAMIS Trial Metastasis-Free Survival The results from the secondary endpoints also favored darolutamide plus ADT. Exploratory endpoints evaluated at the primary analysis included PFS, time to PSA progression, time to rst prostate cancer-related invasive procedure, and time to initiation of subsequent anti-neoplastic therapy, all of which favored darolutamide plus ADT. Overall Survival (OS) Following the primary data cutoff, the ARAMIS study was unblinded on November 30, 2018, and nal data collection cutoff was November 15, 2019. The median follow-up was 29.1 months for the overall study population (11.2 additional months following 2 the primary analysis for MFS). Patient Crossover and Disposition in ARAMIS: At the time of study unblinding, 170 patients from the placebo group crossed over to receive open- 2 label darolutamide plus ADT. At the time of the data cutoff for the nal analysis, 49% (466/954) of patients originally randomized to darolutamide plus ADT were still receiving treatment with darolutamide and 86% (147/170) of patients in the crossover group were still receiving darolutamide. The median treatment exposure for darolutamide group was 18.5 months for the double-blind period and 25.8 months in the combined double-blind and 2 open-label periods. The nal analysis was performed after 254 deaths (148 [16%] in the darolutamide group and 106 [19%]) in the placebo group. Darolutamide plus ADT signicantly reduced the risk of death by 31% (HR 0.69; 95% CI 0.53-0.88, P=0.003) in men with nmCRPC in the nal analysis of the ARAMIS trial. Median OS in months was not reached for both 2 treatment arms (Figure 3). UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE
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