Dr Bilen on Real-World OS Benefit With Apalutamide vs Darolutamide in mCSPC

“In this analysis, we did 24 months of follow up, because that was the available cutoff in this database. [Findings from] the study demonstrated patients who initiated apalutamide without chemotherapy experienced a statistically significant 51% reduction in risk of death compared [with] those who initiated darolutamide without chemotherapy. This is an informative comparison, and I believe it's going to be helpful for all of us.”

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, discusses findings from 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).

Findings from the real-world study demonstrated that patients who received apalutamide ADT without docetaxel (n = 1460) achieved a statistically significant 51% reduction in the risk of death compared with patients treated with darolutamide plus ADT without docetaxel (n = 287; HR, 0.49; 95% CI, 0.30-0.83; P = .007) Bilen began. The study authors performed 24 months of follow-up because that was the available data cutoff in this database, he continued. This comparison will be informative for oncologists because it is among the first of its kind, he concluded.

The real-world analysis was conducted in order to meet FDA guidance on real-world evidence, and included a prespecified protocol, prespecified primary endpoint of overall survival (OS), power calculation, and propensity score matching through inverse probability of treatment weighting.

Data from the real-world study expanded on findings from the phase 3 TITAN trial (NCT02489318), which supported the September 2019 FDA approval of apalutamide for the treatment of patients with mCSPC. In TITAN, patients who received apalutamide plus ADT experienced a significant OS benefit compared with those treated with ADT alone (HR, 0.65; 95% CI, 0.53-0.79; P < .0001).