Darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) led to a 31% reduction in the risk of death compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC), according to results of the final overall survival (OS) analysis of the phase III ARAMIS trial, which were presented during the 2020 ASCO Virtual Scientific Program.
At the primary analysis, the median metastasis-free survival (MFS) was 40.4 months with darolutamide versus 18.4 months with placebo, leading to a 59% reduction in the risk of metastasis or death. Darolutamide had also demonstrated a favorable safety profile, with no increased incidence of most adverse events (AEs) that are associated with the agent, at this time point.
Results also showed that darolutamide significantly delayed time to pain progression, with a median 40.3 months versus 25.4 months with placebo. Nubeqa also delayed the time to first cytotoxic chemotherapy. Dr. Fizazi, however, did note that cardiac arrhythmias, including those of grade 3/4 in severity, were higher with darolutamide (7.3% and 1.8%, respectively) than with placebo (4.3% and 0.7%).
You can read the full news release from CURE here: http://tiny.cc/Nubeqa-darolutamide