Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant
Prostate Cancer Meets Primary Endpoint


A new treatment for prostate cancer patients may be on the horizon as the ARAMIS clinical trial has succeeded in meeting its primary objective, and Bayer has announced that it is moving forward with the steps necessary to bring Darolutamide to patients. ARAMIS was among the initial group of trials included with the launch of PHEN's Clinical Trials Rally.

The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated 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, placebocontrolled trial in patients with nmCRPC. More than 1,500 patients were randomized in a 2:1 ratio to receive 600 mg of Darolutamide twice a day or matching placebo. Darolutamide is an investigational, oral androgen receptor (AR) antagonist developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. 

“Despite recent advances in nmCRPC, there remains a high unmet need for additional treatment options that delay the time to metastases,” said Scott Fields, MD, senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “We are encouraged by the results of the ARAMIS trial and look forward to presenting the full data at an upcoming scientific meeting.”  Bayer has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for Darolutamide in men with nmCRPC.

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