Dr. Lee on the ARAMIS Trial in M0CRPC

Richard (Rick) JaeBong Lee, MD, PhD, medical oncologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, discusses results from the phase III ARAMIS trial in nonmetastatic castration-resistant prostate cancer (M0CRPC).

In the trial, patients were given darolutamide, at 600 mg twice daily or placebo. Patients were blinded to their prostate-specific antigen values. Investigators assessed metastasis-free survival (MFS), defined as the identification of metastasis or death, whichever came first, says Lee. Investigators observed a median MFS of 40.4 months in the darolutamide arm versus 18.4 months in the placebo arm (HR, 0.41; 95% CI, 0.34-0.50; P <.0001).

Other endpoints, including overall survival, also appeared to favor darolutamide although those data are premature. Regarding safety, the adverse events (AEs) observed with darolutamide did not seem to differ substantially from other agents. Patients who received the agent did not appear to have a statistically significant increase in AEs, such as fatigue, seizures, falls, and fractures, which have been some AEs of interest in other trials, explains Lee. In February 2019, a new drug application was filed for darolutamide for use in this setting, although it has yet to receive regulatory approval.