The androgen receptor inhibitor (ARI) darolutamide remains well-tolerated, even with prolonged treatment, among patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), according to a final analysis of the double-blind period of the ARAMIS trial (NCT02200614) presented at the 2021 ASCO Genitourinary Cancers Symposium.
In a presentation on the safety profile of darolutamide, lead author Matthew Raymond Smith, MD, PhD, of the Massachusetts General Hospital Cancer Center, noted that no new safety signals were observed during the double-blind, open-label period of treatment.
“Darolutamide remained well-tolerated with longer exposure in patients with nmCRPC,” Smith said.
ARAMIS randomized 1509 patients with nmCRPC 2:1 to 600 mg darolutamide twice daily (n = 954) or matched placebo (n= 554), while also continuing androgen deprivation therapy. Primary analysis of the DB…