Johnson & Johnson reported positive Phase 3 PROTEUS study results for its prostate cancer drug Erleada (apalutamide). The trial evaluated Erleada combined with androgen deprivation therapy (ADT) administered for six months before and after surgery. This investigational approach targeted patients with high-risk localized or locally advanced prostate cancer.
The final analysis showed the combination treatment reduced the risk of metastasis or death by 20% compared to hormone therapy alone. The Erleada regimen made patients nine times more likely to have little to no cancer remaining at the time of surgery. The study met its two primary goals for significant clinical improvement.
The New England Journal of Medicine published the findings following their presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. Johnson & Johnson plans to work with global regulators to seek approval for this expanded use. These results could establish a new standard of care by shifting the treatment paradigm toward a combination approach.