ERLEADA® (apalutamide) shows significant survival benefits over enzalutamide in metastatic castration-sensitive prostate cancer

Johnson & Johnson recently unveiled groundbreaking findings from the largest real-world, head-to-head study on metastatic castration-sensitive prostate cancer (mCSPC). The study, presented at the 6th European Congress of Oncology Pharmacy (ECOP) in Lisbon, Portugal, revealed that ERLEADA® (apalutamide) significantly reduced the risk of death by 23% at 24 months compared to enzalutamide. This extensive analysis included nearly 4,000 patients, making it the most comprehensive real-world comparison of these two androgen receptor pathway inhibitors (ARPIs) in mCSPC.

The study utilized the U.S. Food and Drug Administration's (FDA) real-world evidence guidelines to ensure the robustness of its findings. It involved a diverse cohort and applied rigorous methodology and data sources. Patients who began treatment with either ERLEADA® or enzalutamide between December 16, 2018, and December 31, 2023, were included in the retrospective analysis. The study encompassed 1,800 patients initiating ERLEADA® and 1,909 patients initiating enzalutamide.

The results demonstrated a significant survival benefit for patients who started with ERLEADA® as their first ARPI, with a 23% reduction in the risk of death after 24 months compared to those who began with enzalutamide. The hazard ratio was 0.77, with a 95% confidence interval ranging from 0.62 to 0.96, and the findings were statistically significant.

ERLEADA® has already been established as an effective treatment for mCSPC, offering a promising option for improving patient survival outcomes. The study further solidifies its position by providing real-world evidence of its effectiveness in reducing mortality rates compared to enzalutamide.

Moreover, the analysis highlighted the safety profile and management of side effects associated with ERLEADA®. Rash and hypothyroidism were among the notable adverse reactions observed. In clinical studies, rash was reported in 24% of patients treated with ERLEADA®, compared to 5.5% with placebo. Most rashes were manageable with antihistamines and corticosteroids, and the onset of rash typically occurred around 83 days after treatment began. Hypothyroidism was reported in 8% of patients treated with ERLEADA®, compared to 1.5% with placebo, with elevated thyroid-stimulating hormone (TSH) levels occurring in 25% of patients on ERLEADA®.

The study's findings are significant as they provide valuable insights into the comparative effectiveness of ARPIs in a real-world setting. This information can guide clinicians in making informed treatment decisions for patients with mCSPC, potentially leading to improved patient outcomes and survival rates.

Johnson & Johnson's dedication to advancing healthcare innovation is evident through this study, which underscores their commitment to improving patient care through rigorous research and evidence-based practices. The results presented at the ECOP conference highlight ERLEADA®'s potential to offer substantial survival benefits for patients with mCSPC, reinforcing its role as a critical treatment option in this therapeutic area.

This landmark study not only provides compelling evidence of ERLEADA®'s efficacy but also underscores the importance of real-world evidence in understanding treatment outcomes. The continued exploration of ARPIs and their impact on mCSPC will be crucial in the ongoing effort to enhance therapeutic strategies and improve the quality of life for patients battling prostate cancer.

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