Darolutamide Plus ADT for Nonmetastatic Prostate Cancer: Final Update From ARAMIS
Posted: Wednesday, August 5, 2020
Final analyses from the phase III ARAMIS study, presented during the ASCO20 Virtual Scientific Program (Abstract 5514), reported that darolutamide plus continued androgen-deprivation therapy (ADT) in patients with nonmetastatic castration-resistant prostate cancer demonstrated a statistically significant overall survival benefit. The distinct androgen receptor inhibitor also delayed the start of cancer-related symptoms and subsequent chemotherapy when compared with placebo, concluded Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, Villejuif, France, and colleagues.
“With extended follow-up, safety and tolerability were favorable and consistent with the primary ARAMIS analysis,” the authors noted.
In this trial, the authors assigned 1,509 patients with nonmetastatic castration-resistant prostate cancer to receive 600 mg of darolutamide twice daily (955 patients) or a placebo (554 patients) while continuing treatment with ADT. The final analysis of the patients occurred after 254 patients died (15.5% of patients treated with darolutamide and 19.1% of those in receipt of a placebo.)
After the investigators unblinded the primary analysis, 170 patients switched from a placebo to treatment with darolutamide. Patients treated with darolutamide had a statistically significant overall survival benefit that corresponded to a 31% reduction in the risk of death compared with patients treated with a placebo. In addition, all secondary endpoints (overall survival, time to pain progression, first cytotoxic chemotherapy, and first symptomatic skeletal event) observed by the authors were improved with darolutamide, regardless of crossover from placebo and subsequent therapies.
Occurrence of treatment-emergent adverse events with at least 5% frequency was generally comparable between darolutamide and placebo. Adverse events of interest (including falls, central nervous system effects, and hypertension) were not increased among patients treated with darolutamide compared with those who received placebo when adjusted for treatment exposure.
Disclosure: For full disclosure of the study authors, visit coi.asco.org.
