Karim Fizazi, MD, PhD

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.

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Karim Fizazi, MD, PhD, discusses the potential role for darolutamide in combination with androgen deprivation therapy in patients with nonmetastatic castration-resistant prostate cancer.

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

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.&nbsp;

As a result of the phase III ARAMIS trial,

darolutamide was recently granted a priority review designation by the FDA

was 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;

Karim Fizazi, MD, PhD,head of the Department of Cancer Medicine,&nbsp;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, recently presented during the 2019 ASCO Annual Meeting.&nbsp;<br />
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Karim Fizazi, MD, PhD | Authors

Articles

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

Achieving MFS and Improved Quality of Life in nmCRPC With Darolutamide