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Achieving MFS and Improved Quality of Life in nmCRPC With Darolutamide

Karim Fizazi, MD, PhD
Published Online:3:00 PM, Tue July 16, 2019

Karim Fizazi, MD, PhD,head of the Department of Cancer Medicine, Institut Gustave Roussy, University of Paris-Sud, gives highlights on the updated findings from the phase III ARAMIS trial using darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), recently presented during the 2019 ASCO Annual Meeting. 

As a result of the phase III ARAMIS trial, darolutamide was recently granted a priority review designation by the FDA for treatment of nmCRPC.

The ARAMIS studywas designed to address the aspects of nmCRPC that directly impact the patient—ie, disease symptoms, prostate-specific antigen (PSA) and anxiety, quality of life, and survival. With 1590 patients randomized 2:1 to receive either 600 mg of darolutamide twice daily (n = 955) or placebo (n = 554), the aim was to achieve a primary endpoint of improved metastasis-free survival (MFS) and 2 secondary endpoints, overall survival (OS) and time to pain progression. 

With darolutamide, quality of life in patients was maintained and symptoms were prevented. Specifically, subjects in the darolutamide arm showed more delay in pain progression (HR, 0.65; 95% CI, 0.53-0.79; P<.001), prolonged MFS, and improvement in disease symptoms, including pain, urinary, and bowel conditions compared with placebo. The study is active and gathering more data to determine overall survival associated with darolutamide treatment for patients with nmCRPC, says Fizazi.
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