Results from the Phase III Aramis trial has significantly extended survival rates (metastasis free) in patients with nonmetastatic castration-resistant prostate cancer ( NMCRPC) with the agent, DAROLUTAMIDE.
Darolutamide is a unique nonsteroidal androgen-receptor antagonist that is structurally distinct from other androgen-receptor inhibitors, and consists of two pharmacologically active diastereomers. Data from preclinical studies suggested that it may have fewer and less severe toxicities than other agents due to its low penetration of the blood–brain barrier, and low binding affinity for γ-aminobutyric acid type A receptors.
The ARAMIS trial is a double-blind, placebo-controlled phase III trial that randomized 1509 men with nmCRPC to receive darolutamide 600 mg (two 300 mg tablets) twice daily or placebo, while continuing on androgen deprivation therapy. The primary endpoint was metastasis-free survival (MFS), with independent central review of radiographic imaging every 16 weeks.
An independent comment from Bobby Liaw, MD, clinical director of genitourinary oncology at Mount Sinai Health System in New York City said that the study showcased the activity and efficacy of a new oral androgen receptor antagonist in delaying the development of radiographically evident metastatic disease in men with nmCRPC.
Commenting on the ARAMIS trial, Liaw said: “Additional follow-up will be able to further define the adverse effect profile of darolutamide, but because it does not cross the blood–brain barrier to any significant degree, it may potentially be associated with less fatigue, falls, and seizure risk, as compared to apalutamide or enzalutamide.”
Edited from MedScape News