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ARAMIS Trial: Darolutamide in Nonmetastatic Prostate Cancer

By: Anna Nowogrodzki
Posted: Monday, April 1, 2019

The androgen receptor antagonist darolutamide prolonged metastasis-free survival in patients with nonmetastatic castration-resistant prostate cancer, according to the phase III ARAMIS trial. In fact, darolutamide was linked to benefits in regard to all secondary study endpoints, including overall survival, time to pain progression, time to cytotoxic chemotherapy, and time to asymptomatic skeletal event. The research was published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract 140) by Karim Fizazi, MD, of the Institut Gustave Roussy, France, and colleagues.

The authors noted that darolutamide is a “structurally unique” androgen receptor antagonist, as it does not penetrate the blood-brain barrier well and has low binding affinity for γ-aminobutyric acid type A receptors.

The double-blind, placebo-controlled trial included 1,509 patients with nonmetastatic castration-resistant prostate cancer. Patients were randomly assigned: two-thirds (955) received darolutamide (600 mg twice a day) and one-third (554) received a placebo. Randomization was stratified by prostate-specific antigen doubling time (6 months or less, or more than 6 months) and use of osteoclast-targeted therapy. All patients continued androgen-deprivation therapy.

The median metastasis-free survival was 40.4 months with darolutamide compared with 18.4 months with a placebo (hazard ratio for metastasis or death with darolutamide = 0.41; P < .001). In addition to a “trend in favor of darolutamide” in terms of the secondary study endpoints previously mentioned, the researchers found little to no difference in fractures, falls, seizures, weight decrease, hypertension, and cognitive disorders between the two treatments. There were similar rates of patients dropping out because of adverse events in both treatment arms: 8.9% for darolutamide and 8.7% for the placebo. However, of note, the trial is limited by its small number (52) of patients of African descent.

Disclosure: The study authors’ disclosure information may be found at nejm.org.



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