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The Addition of Darolutamide to ADT Reduces Risk of Metastasis in Nonmetastatic CRPC

Karim Fizazi, MD, PhD
Published Online:11:37 AM, Tue August 20, 2019

Karim Fizazi, MD, PhD, head of the Department of Cancer Medicine at the Institut Gustave Roussy, Villejuif, France, discusses the potential role for darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) in patients with nonmetastatic castration-resistant prostate cancer (CRPC).

According to data from the phase III ARAMIS trial, darolutamide, when combined with ADT, resulted in a median metastasis-free survival of 40.4 months compared with 18.4 months with ADT alone. There was also a trend toward improvement in overall survival (OS), but the median OS data were still not mature. The 3-year OS rate is 83% with the combination versus 73% with ADT alone, Fizazi says.

The addition of darolutamide led to a 59% reduction in the risk of metastasis or death. The drug also had a good safety profile with minimal adverse events compared to placebo. Quality of life, assessed by the FACT-P and EORTC questionnaire, was maintained with the combination versus ADT alone.

Within the next few months, Fizazi expects to see the final analysis from the ARAMIS trial presented at an upcoming meeting following the recent FDA approval for the androgen receptor inhibitor. He believes darolutamide may have the potential to postpone death on top of metastases and symptoms in patients with CRPC.
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