2 UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE ARAMIS: A Phase III Study of darolutamide in Men with High-risk Non-metastatic Castration-resistant Prostate Cancer MA-M_DAR-ZA-0015-1 Summary • Darolutamide is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration1 resistant prostate cancer (nmCRPC). • ARAMIS, a Phase III, randomized, double-blind, placebo-controlled multinational study, evaluated the efcacy and safety of darolutamide in men being treated with androgen deprivation therapy (ADT*) for nmCRPC with a high risk of developing metastases (PSADT of ≤ 10 months and PSA ≥ 1,2,3 2ng/ml). Patients (N = 1509) were randomized 2:1 to receive darolutamide 600 mg tablets orally twice daily plus ADT* versus matching placebo plus ADT*. * Common previous hormonal therapies for prostate cancer (received by ≥10% of all patients) included leuprolide (52%), goserelin (32%), triptorelin (29%), bicalutamide (66%), utamide (13%), and cyproterone (11%). In the primary analysis of the Phase III ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) signicantly prolonged metastasis free survival (MFS) (median 40.4 months) compared to placebo plus ADT 1,3 (median 18.4 months). In the nal analysis of the ARAMIS trial: • Darolutamide plus ADT signicantly improved overall survival (OS), with a 31% reduction in risk of death compared with placebo plus ADT, in men with nmCRPC (hazard ratio [HR] 0.69; 95% condence interval [CI] 0.53-0.88, 2 P=0.003) • Treatment with darolutamide plus ADT signicantly improved all other secondary endpoints, including time to pain progression (HR 0.65; 95% CI 0.53-0.79, P<0.001), time to cytotoxic chemotherapy (HR 0.58; 95% CI 0.440.76; P<0.001), and time to rst symptomatic skeletal event (SSE) (HR 0.48; 95% CI 0.29-0.82, 2 P=0.005) • The nal analysis of the safety prole of darolutamide was generally consistent with 2,4 the primary analysis. The incidences of treatment-emergent adverse events were similar between patients who received darolutamide plus ADT and those who 2-4 received placebo + ADT. The AE with an incidence of ≥10% was fatigue (13.2% in the darolutamide group versus 8.3% in the placebo group). No new safety signals were 2 observed in the nal analysis. CLINICAL DATA ARAMIS Trial Background Study Design ARAMIS a global, randomized, double-blind, placebo-controlled phase 3 trial evaluated the efcacy and safety of darolutamide plus ADT versus placebo plus ADT in men with nmCRPC (Error! 1-3 Reference source not found.). Men with nmCRPC and a prostate-specic antigen doubling time (PSADT) of ≤10 months were randomized 2:1 to receive either darolutamide 600 mg twice daily 2,3 plus ADT or placebo plus ADT. The primary endpoint was metastasis free survival (MFS). Secondary outcomes included overall survival (OS), time to pain progression (TPP), time to rst cytotoxic chemotherapy, time to rst symptomatic skeletal events (SSE), and safety. 1-3 Figure 1. ARAMIS Trial Design This is a CPD accredited article, please click on the link below to complete the questionnaire for CPD points: https://bayerag.eu.qualtrics.com /jfe/form/SV_3Og96dqvI7GYvyu
RkJQdWJsaXNoZXIy NTIyOTQ=