Darolutamide and survival in metastatic, hormone-sensitive prostate cancer

Darolutamide is an androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. The multinational phase 3 ARASENS study evaluated darolutamide versus placebo, both in combination with androgen-deprivation therapy and docetaxel, in patients with metastatic hormone-sensitive prostate cancer. The risk of death was significantly lower, by 32.5%, in de darolutamide group than in the placebo group (HR 0.68; p<0.001). Outcomes were also better with darolutamide than with placebo for secondary endpoints (time to CRPC, time to initiation of subsequent anticancer therapy, SSE-free survival, time to pain progression, and time to worsening of physical symptoms). Adverse events were similar in both groups.