Johnson & Johnson announced final Phase 3 PROTEUS study results for ERLEADA (apalutamide). The drug significantly improved outcomes for patients with high-risk localized or locally advanced prostate cancer.
ERLEADA combined with hormone therapy reduced the risk of cancer spreading or death by 20% compared to placebo plus hormone therapy. The study met both primary endpoints when administered before and after surgery.
Patients using the ERLEADA regimen were nine times more likely to show little to no cancer remaining after surgery. This result suggests a potential shift in the long-standing treatment approach for this patient population.
The findings earned a plenary presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The New England Journal of Medicine simultaneously published the study results.