Key clinical point: Darolutamide is efficacious and well tolerated when used to treat nonmetastatic, castration-resistant prostate cancer.
Major finding: Median metastasis-free survival was 40.4 months with darolutamide versus 18.4 months with placebo (hazard ratio, 0.41; P less than .0001).
Study details: A phase 3, randomized, controlled trial among 1,509 men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less who continued on androgen deprivation therapy.
Disclosures: Dr. Fizazi reported that he receives honoraria from Astellas Pharma, Janssen, Merck, and Sanofi; that he has a consulting or advisory role with Amgen, Astellas Pharma, AstraZeneca, Bayer, Clovis Oncology, CureVac, ESSA, Janssen Oncology, Orion Pharma, Roche/Genentech, and Sanofi; and that he receives travel, accommodations, and/or expenses from Amgen and Janssen. The trial was sponsored by Bayer.
Fizazi K et al. GUCS 2019, Abstract 140.