Phase III ARAMIS trial of BAY 1841788 meets primary endpoint in prostate cancer.- Orion + Bayer.

Orion and Bayer have announced that the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated BAY 1841788 (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC), met its primary endpoint. Darolutamide significantly extended metastasis-free survival (MFS) compared to placebo. The safety profile and the tolerability of darolutamide observed in the ARAMIS trial were consistent with previously published data on darolutamide. ARAMIS is a randomized, multi-center, double-blind, placebo-controlled trial in patients with nmCRPC.

Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission of a new drug application. Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC.