Darolutamide Demonstrates Efficacy and Safety in Men with nmCRPC - Neeraj Agarwal

February 26, 2019

Petros Grivas discussed Neeraj Agarwal's insights about the latest prostate cancer study results that will impact patient care as presented at ASCO GU 2019.  The ARAMIS trial evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.  Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. Neeraj discusses the interim analysis Karim Fizazi presented on the Efficacy and Safety Study of Darolutamide in Men With High-risk Nonmetastatic Castration-resistant Prostate Cancer (ARAMIS).  

In total, 1509 patients underwent randomization (955 to the darolutamide group and 554 to the placebo group). In the planned primary analysis, which was performed after 437 primary end-point events had occurred, the median metastasis-free survival was 40.4 months with darolutamide, as compared with 18.4 months with placebo (hazard ratio for metastasis or death in the darolutamide group, 0.41; 95% confidence interval, 0.34 to 0.50; P<0.001). 

Neeraj and Petros also discuss the results of the final analysis of LATITUDE and the first results as presented in metastatic hormone sensitive prostate cancer (mHSPC) patients from the ARCHES trial.  The results show that enzalutamide plus androgen deprivation therapy (ADT) met the primary endpoint by significantly reducing the risk of radiographic progression or death by 61% versus ADT alone (n=1,150; HR=0.39 [95% CI: 0.30-0.50]; p<0.0001).  The treatment of prostate cancer has continued to evolve since 2010 and the new data presented here adds to the opportunities in treating men with advanced prostate cancer.


Neeraj Agarwal, MD, Professor in the Division of Oncology, Department of Medicine, at the Huntsman Cancer Institute (HCI) at the University of Utah School of Medicine. He is the Huntsman Cancer Institute (HCI) Presidential Endowed Chair of Cancer Research, and the Director of the Genitourinary Oncology Program, Dr. Agarwal also serves as the physician-scientist and senior director of clinical research innovation at HCI, Salt Lake City, Utah

Petros Grivas,MD, PhD is a medical oncologist at Seattle Cancer Care Alliance with expertise in genitourinary cancers such as bladder cancer, prostate cancer and testis cancer. Clinical Director, Genitourinary Cancers Program, University of Washington Medicine, Associate Professor, Department of Medicine, Division of Oncology, University of Washington School of Medicine