- Study shows 51% reduction in death risk for mCSPC patients treated with ERLEADA® vs. darolutamide over 24 months.
- 1,460 ERLEADA® patients and 287 darolutamide patients were analyzed from August 2022 to June 2025.
- ERLEADA® plus ADT treatment shows rapid PSA decline linked to prolonged overall survival.
- TITAN trial confirmed significant OS benefit for ERLEADA® plus ADT compared to ADT alone.
Study Overview
Johnson & Johnson's recent study highlights a 51% reduction in the risk of death for patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with ERLEADA® compared to darolutamide, without the use of docetaxel, over a 24-month period. The study was presented at the 36th Annual International Prostate Cancer Update.
Methodology
The study adhered to FDA guidelines on real-world evidence, employing a pre-specified protocol, primary endpoint of overall survival, power calculation, and propensity score matching through inverse probability of treatment weighting. It included 1,460 patients treated with ERLEADA® and 287 with darolutamide, identified between August 2022 and June 2025.
Findings
Results indicate a significant survival benefit for ERLEADA® without concurrent docetaxel use, consistent with other datasets showing similar benefits over commonly used agents. The study supports clinical decision-making in the absence of prospective head-to-head trials.
Supporting Data
Previous findings from the Phase 3 TITAN trial demonstrated a statistically significant overall survival benefit for mCSPC patients treated with ERLEADA® plus androgen deprivation therapy (ADT) compared to ADT alone. The TITAN trial involved 1,052 patients and showed a consistent survival rate at 24 months, aligning with the real-world analysis.
