HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) reported new real-world evidence showing that patients with metastatic castration-sensitive prostate cancer who began treatment with ERLEADA without chemotherapy experienced a sharply lower risk of death compared with those treated with darolutamide over two years of follow-up.
The head-to-head analysis found a 51 percent reduction in the risk of death for patients initiating ERLEADA without docetaxel, with a hazard ratio of 0.49 and a statistically significant P value of 0.007. The findings are being presented at the 36th Annual International Prostate Cancer Update, where the study was selected as a top abstract.
The retrospective study evaluated patients treated in routine clinical practice between August 2022 and June 2025 and was designed to meet U.S. Food and Drug Administration standards for real-world evidence. Researchers analyzed outcomes for 1,460 patients who started ERLEADA and 287 patients who initiated darolutamide, applying rigorous statistical methods to balance baseline characteristics between groups.
“These real-world data show the survival benefit of apalutamide versus darolutamide in patients with mCSPC without the concurrent use of docetaxel,” said Dr. Mehmet Bilen, director of the Genitourinary Medical Oncology Program at Emory University’s Winship Cancer Institute. He said the analysis helps guide treatment decisions in the absence of prospective head-to-head trials, which are difficult to conduct.
Johnson & Johnson said the results build on prior evidence supporting ERLEADA, including findings from the Phase 3 TITAN trial, which demonstrated a statistically significant overall survival benefit for patients treated with ERLEADA plus androgen deprivation therapy compared with androgen deprivation therapy alone. In the TITAN study, survival benefits were observed both at the primary analysis and at final follow-up after a median of 44 months.
Company officials said the real-world data reinforce ERLEADA’s role as a key standard-of-care option for patients with metastatic castration-sensitive prostate cancer.
“Real-world comparisons can provide critical information to support patient care when conducted in a rigorous and methodologically sound manner,” said Dr. Mahadi Baig, vice president of U.S. Medical Affairs at Johnson & Johnson Innovative Medicine.
Approximately 330,000 people are diagnosed with prostate cancer in the United States each year, and more than 36,000 men are projected to die from the disease in 2026, underscoring the importance of early and effective treatment choices for advanced cases.
ERLEADA, also known as apalutamide, is an androgen receptor inhibitor approved by the FDA for both non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer. More than 325,000 patients worldwide have been treated with the therapy to date.
Additional information about ERLEADA is available at www.ERLEADA.com.
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