Johnson & Johnson announced new real world head-to-head evidence demonstrating that patients with metastatic castration-sensitive prostate cancer (mCSPC) initiating ERLEADA® without docetaxel experienced a statistically significant 51% reduction in the risk of death compared to those who initiated on darolutamide without docetaxel through 24-months of follow-up (hazard ratio [HR] 0.49; 95% confidence interval [CI, 0.30-0.83; P=0.007). These findings reflecting patients treated in routine clinical practice are being presented at the 36th Annual International Prostate Cancer Update on February 2, where it was selected as a top abstract (Abstract #6). Designed to meet rigorous FDA guidance and robust methodological framework on real-world evidence, this study included a pre-specified protocol, pre-specified primary endpoint of overall survival (OS), power calculation, and propensity score matching through inverse probability of treatment weighting (IPTW).
Together, these methodological safeguards deliver robust, reproducible insights that inform real-world treatment decisions. The prospective study identified mCSPC patients who initiated ERLEADA® or darolutamide without Docetaxel between August 2022 and June 2025. IPTW demonstrated a statistically significant OS benefit for mCSPC patients treated with ERLEADA® plus ADT compared to ADT alone at the primary analysis after a median 22.7 months of follow-up (HR 0.67; 95% CI, 0.51-0.89; P=0.005) and at the final analysis after a median 44 months of follow-up (HR 0.65; 95% CI, 0.,53-0.79; PAbout the Study: These real-world findings adhere to the rigorous standards set by the U.S. FDA, including providing comparative effectiveness evidence from large, contemporary U.S. datasets used in routine clinical practice, peer-reviewed methods, and strict study monitoring.
Complementing randomized controlled trials, real-world evidence can help inform clinical decisions, including comparative data into treatments, by collecting a plethora of data from a diverse range of patients in the real-world setting. Some limitations of this study include potential miscoding or missing information in the data sources; however, the data sources used in this study were deemed fit for purpose to identify the patient population correctly and to assess survival. IPTW, a propensity score matching statistical method, was employed to balance baseline characteristics between treatment groups, removing bias from measured confounders and replicating the conditions of a randomized clinical trial.
