How Darolutamide’s Safety Profile in nmCRPC Differs from Similar Agents

February 13, 2021

Patrick G. Pilié, MD, explains how the safety profile of darolutamide, as seen in the ARAMIS clinical trial, differs from those of enzalutamide and apalutamide.

Patrick G. Pilié, MD, an assistant professor of the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center in Houston, Texas, explains how the safety profile of darolutamide (Nubeqa), as seen in the ARAMIS clinical trial (NCT02200614), differs from those of enzalutamide (Xtandi) and apalutamide (Erleada), as evaluated in the PROPSER (NCT02003924) and SPARTAN (NCT01946204) clinical trials.

In the all 3 randomized phase 3 trials, the antiandrogen agents showed improvement metastasis-free survival and overall survival (OS) in patient, and Pilié says that the results are both biologically and clinical reassuring. In ARAMIS, in particular, the OS benefit was a 31% reduction in the risk of death. Aside from OS, the unique feature about darolutamide is the safety profile, explains Pilié.

In comparison to what was observed with enzalutamide and apalutamide, data from darolutamide showed less of a increased risk for fracture, hypertension, cognitive impairment, and seizures.