Darolutamide in Metastatic Castrate-Resistant Prostate Cancer


A key opinion leader discusses impact of ADTs on brain and cognitive function in men with prostate cancer.

Karim Fizazi, MD, PhD: Enzalutamide, apalutamide, and darolutamide are all approved for use in nonmetastatic castration-resistant prostate cancer, with similar outcomes for efficacy, including overall survival, and seemingly different safety profiles, with no marked difference between darolutamide and its placebo regarding adverse effects. In regard to metastatic castration-sensitive disease, we have data for apalutamide, enzalutamide, and abiraterone; all 3 drugs show overall survival improvement in sometimes different spaces like high risk or low risk, but these 3 drugs work.

We don’t have data with darolutamide in the metastatic castration-sensitive space. We are waiting for the ARASENS large phase 3 trial, which is comparing androgen deprivation therapy plus docetaxel with or without darolutamide. This is eagerly awaited because we recently reported the PEACE-1 data indicating that the triplet treatment with abiraterone improves overall survival. I hope that this is also the case with darolutamide, and data will tell, hopefully soon.

Now, regarding men with metastatic castration-resistant prostate cancer, enzalutamide and abiraterone are approved, while apalutamide and darolutamide are not because we don’t have phase 3 data in this space for these 2 agents.

Transcript edited for clarity.

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