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

San Francisco, CA USA (UroToday.com) -- 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, placebo-controlled trial in patients with nmCRPC. 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 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 U.S. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC.

The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) and are at risk for developing metastatic disease. More than 1,500 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo.

The primary endpoint of this trial is metastasis-free survival (MFS), defined as time between randomization and evidence of metastasis or death from any cause. The secondary objectives of this trial are overall survival (OS), time to first symptomatic skeletal event (SSE), time to initiation of first cytotoxic chemotherapy, time to pain progression and characterization of the safety and tolerability of darolutamide.

References
1. Nakazawa, Mary; Paller, Channing; Kyprianou, Natasha.  Mechanisms of Therapeutic Resistance in Prostate Cancer. Curr Oncol Rep (2017) 19:13.
2. Howard, Lauren; Moreira, Daniel M; DeHoedt, Amanda; Aronson, William J., et al.  Thresholds for PSA doubling time in men with non-metastatic castration-resistant prostate cancer.  BJU Int 2017; 120: E80-E86.

Further Related Content:
Read: Darolutamide Receives FDA Approval for the Treatment of Non-metastatic Castration-resistant Prostate Cancer 
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