Johnson & Johnson has reported new real-world, head-to-head evidence indicating improved overall survival for patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with ERLEADA® (apalutamide) without docetaxel, compared with darolutamide without docetaxel.
The findings were selected as a top abstract and are being presented at the 36th Annual International Prostate Cancer Update on February 2.
The retrospective analysis showed that patients initiating ERLEADA® experienced a statistically significant 51 percent reduction in the risk of death over 24 months of follow-up compared with those receiving darolutamide. The hazard ratio for overall survival was 0.49, with a 95 percent confidence interval of 0.30 to 0.83 and a P value of 0.007. The study evaluated outcomes in routine clinical practice, reflecting real-world treatment patterns.
Designed in alignment with U.S. FDA guidance on real-world evidence, the study followed a pre-specified protocol with overall survival as the primary endpoint, included a power calculation, and applied propensity score matching using inverse probability of treatment weighting to minimise baseline imbalances. The analysis identified mCSPC patients who initiated treatment without docetaxel between August 2022 and June 2025, comprising 1,460 ERLEADA® initiators and 287 darolutamide initiators who met the study criteria.
The real-world overall survival outcomes build on earlier evidence demonstrating rapid and sustained prostate-specific antigen decline with ERLEADA® plus androgen deprivation therapy (ADT), which has been associated with prolonged survival. These findings are consistent with results from the Phase 3 TITAN trial, a multinational, randomised, double-blind, placebo-controlled study involving 1,052 patients with mCSPC. In TITAN, ERLEADA® plus ADT demonstrated a statistically significant overall survival benefit compared with ADT alone at both the primary and final analyses, with hazard ratios of 0.67 and 0.65, respectively.
In the current real-world analysis, 92.1 percent of patients treated with ERLEADA® were alive at 24 months, a rate broadly consistent with survival outcomes observed in the TITAN trial. In TITAN, all patients received concurrent gonadotropin-releasing hormone therapy or had undergone prior bilateral orchiectomy, with overall survival and radiographic progression-free survival as dual primary endpoints.
The study reinforces the role of rigorously conducted real-world evidence in informing clinical decision-making, particularly in the absence of prospective head-to-head trials. Investigators used large contemporary U.S. datasets and applied propensity score matching to adjust for baseline patient characteristics and support fair comparative assessment of outcomes.
While limitations such as potential miscoding or missing data were acknowledged, the datasets were considered appropriate for evaluating survival, and statistical methods were applied to mitigate measured confounding.
Prostate cancer remains one of the most common cancers in the United States, with approximately 330,000 new diagnoses annually. Up to 40 percent of patients are classified as high-risk, and disease recurrence affects up to half of patients within ten years following surgery.
More than 36,000 deaths from prostate cancer are projected in 2026, underscoring the importance of early and effective treatment selection for patients with advanced disease.
