ERLEADA Shows 51% Reduction in Death Risk Versus Darolutamide in Real-World Prostate Cancer Study
核心洞察
Johnson & Johnson announced real-world evidence showing ERLEADA (apalutamide) reduced death risk by 51% compared to darolutamide in metastatic castration-sensitive prostate cancer (搜索) patients without docetaxel through 24 months.
The retrospective study included 1,460 ERLEADA patients and 287 darolutamide patients, using rigorous FDA-guided methodology with propensity score matching to ensure fair comparison.
The findings build upon Phase 3 TITAN trial results and support apalutamide as a key standard of care treatment for mCSPC patients.
Johnson & Johnson announced new real-world evidence demonstrating that patients with metastatic castration-sensitive prostate cancer (搜索) (mCSPC) initiating ERLEADA® (apalutamide) without docetaxel experienced a statistically significant 51% reduction in the risk of death compared to those who initiated 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).
The findings were presented at the 36th Annual International Prostate Cancer (搜索) Update on February 2, where the study was selected as a top abstract. The retrospective analysis identified mCSPC patients who initiated ERLEADA® or darolutamide without docetaxel between August 2022 and June 2025, including 1,460 ERLEADA® patients and 287 darolutamide initiators who met study criteria.
Rigorous Methodology Ensures Robust Results
The study was designed to meet rigorous FDA guidance and robust methodological framework on real-world evidence, incorporating 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). Study investigators applied propensity score matching (PSM) to match the apalutamide and darolutamide groups through adjusting for baseline differences in measured patient characteristics.
"These real-world data show the survival benefit of apalutamide versus darolutamide in patients with mCSPC without the concurrent use of docetaxel," said Mehmet Bilen, M.D., Director, Genitourinary Medical Oncology Program, Winship Cancer Institute of Emory University. "The results are consistent with other datasets showing similar overall survival benefit versus other commonly used agents."
Clinical Context and Significance
The proportion of patients alive at 24 months (92.1%) observed in the ERLEADA® cohort in this real-world analysis is generally consistent with that reported in the Phase 3 TITAN trial (82.4%). The TITAN study demonstrated a statistically significant OS benefit for mCSPC patients treated with ERLEADA® plus androgen deprivation therapy (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; P<0.0001).
"Real-world comparisons can provide critical information to support patient care when conducted in a rigorous and methodologically sound manner," said Mahadi Baig, M.D., M.H.C.M., Vice President, U.S. Medical Affairs, Johnson & Johnson Innovative Medicine. "We have now seen in repeated real-world examinations the overall survival benefit of apalutamide versus other agents and this head-to-head analysis supports apalutamide being a key standard of care treatment for patients with mCSPC."
Study Limitations and Methodology
The study acknowledged some limitations, including potential miscoding or missing information in the data sources. However, the data sources used 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.
Disease Burden and Treatment Landscape
Approximately 330,000 people are diagnosed with prostate cancer (搜索) each year in the U.S., with up to 40% of patients classified as high-risk. Despite advancements in treatment, disease recurrence remains substantial, with up to 50% of patients within ten years of surgery experiencing recurrence and carrying a significant risk of disease progression and death. It's estimated that more than 36,000 men will succumb to prostate cancer in 2026.
ERLEADA® (apalutamide) is an androgen receptor (搜索) inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (搜索) (nmCRPC) and metastatic castration-sensitive prostate cancer (搜索) (mCSPC). The drug received U.S. FDA approval for nmCRPC in February 2018 and for mCSPC in September 2019. To date, more than 325,000 patients worldwide have been treated with ERLEADA®.