First presentation of data from the Phase III ARAMIS trial with the investigational compound darolutamide in patients with advanced prostate cancer that has not yet metastasized will be presented at 2019 ASCO GU Cancers Symposium, taking place February 14-16 in San Francisco.
Among the data presented will be the first results on the investigational cancer treatment darolutamide from the Phase III ARAMIS trial, a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of darolutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) being treated with androgen deprivation therapy (ADT) and at high risk for developing metastatic disease. Darolutamide is being developed jointly by Orion Corporation and Bayer.
Bayer plans to discuss data from the ARAMIS trial with health authorities regarding the submission of a new drug application. Darolutamide has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in patients with nmCRPC.