Dr. Shore on the Long-term Safety of Darolutamide in nmCRPC

Neal Shore, MD, FACS, US chief medical officer, Surgery and Oncology, GenesisCare USA, the medical director, Carolina Urologic Research Center, discusses the continued evaluation of darolutamide (Nubeqa) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

In July 2019, the FDA approved darolutamide for the treatment of patients with nmCRPC, which was supported by the phase 3 ARAMIS study (NCT02200614). Investigators assessed the long-term tolerability of darolutamide in patients with nmCRPC in the phase 3 ARAMIS rollover trial (NCT04464226). The rollover trial included patients from ARAMIS who had no evidence of metastases and were benefiting clinically from treatment with darolutamide at the end of the original ARAMIS trial.

Findings from the rollover study presented at the 2023 Genitourinary Cancers Symposium showed that the median duration of treatment was 1.5 years in a double-blind (DB) period, 2.1 years in the DB plus open-label (OL) periods, and 2.8 years for the DB, OL, and rollover (ROS) periods, Shore begins. At the time January 31, 2022, data cutoff, 62.4% of the 954 patients had received darolutamide for at least 2 years, 30.1% of patients received the drug for at least 4 years, and 12.8% of patients continued on darolutamide for at least 5 years. At the time of data cutoff, 24% of the patients were still receiving darolutamide, Shore adds.

Investigators examined treatment-emergent adverse effects (TEAEs), such as grade 3/4 toxicities, or serious toxicities, across the DB, OL, and ROS periods. Shore continues. Rates of treatment discontinuation rates dur to TEAEs during the DB, DB plus OL, and DB plus OL and ROS periods were 8,9%, 10.5%, and 12.9%, respectively. These data demonstrated how well tolerated the drug was with each passing year, Shore notes. Additionally, Serious AEs ranged from occurred in 26.1% of patients during the DB period, 32.1% in the DB plus OL period, and 38.5% in the DB plus OL and ROS period.

These data and long-term follow-up from the ARAMIS trial show that darolutamide is a well-tolerated drug and should be of special consideration when treating patients, Shore says. No new safety signals for were observed with longer treatment with darolutamide in the rollover study, Shore concludes.