Dr Bilen on a Real-World Analysis of Apalutamide vs Darolutamide in mCSPC

“We saw a meaningful separation [in the curve] for survival in this retrospective real-world analysis. This was one of the first comparisons between those 2 agents, [which] is why I believe it is quite helpful and informative for [oncologists] who treat [patients with] prostate cancer.”

Mehmet Bilen, MD, director of the Genitourinary Medical Oncology Program at the Winship Cancer Institute of Emory University and a professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, discussed the rationale for conducting a real-world analysis of apalutamide (Erleada) plus androgen deprivation therapy (ADT) vs darolutamide (Nubeqa) plus ADT, both without docetaxel, for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

Investigators conducted a real-world head-to-head comparison of apalutamide vs darolutamide in patients with mCSPC, which is a commonly seen population in clinic, Bilen began. The analysis included patients who initiated either apalutamide or darolutamide, in combination with ADT and without docetaxel, he noted. The study is among the first comparisons of its kind between the 2 agents, making it informative for oncologists who treat patients with mCSPC, he said.

The real-world study included patients who started apalutamide (n = 1460) or darolutamide (n = 287) between August 2022 and June 2025. Investigators used propensity score matching to adjust for baseline differences in measured characteristics. After 24 months of follow-up, patients in the apalutamide group experienced a 51% reduction in the risk of death compared with the darolutamide group (HR, 0.49; 95% CI, 0.30-0.83; P = .007).

In September 2019, the FDA approved apalutamide for the treatment of patients with mCSPC. The regulatory decision was supported by data from the phase 3 TITAN trial (NCT02489318). Findings from the final analysis of TITAN showed that patients who received apalutamide plus ADT experienced a significant overall survival benefit compared with those treated with ADT alone (HR, 0.65; 95% CI, 0.53-0.79; P < .0001).