Key Takeaways:
Johnson & Johnson's Erleada reduced the risk of metastasis or death by 20% in patients with high-risk localized prostate cancer, meeting both primary endpoints in a Phase 3 trial.
The data from the PROTEUS study were selected for the plenary session at the American Society of Clinical Oncology annual meeting in Chicago and published simultaneously in the New England Journal of Medicine.
The trial evaluated six months of apalutamide (Erleada) plus androgen deprivation therapy before and after radical prostatectomy. Patients receiving the combination were nine times more likely to have little to no cancer remaining in the prostate after surgery compared with those who received ADT alone, the company said.
Prostate cancer is the second most common cancer in men worldwide, with about 330,000 new cases expected in the U.S. in 2026. The perioperative setting represents a large potential label expansion for Erleada, which is currently approved for non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
The results break a decades-long treatment paradigm where systemic therapy before and after surgery was not standard practice for localized disease, J&J said. The company plans to discuss the data with regulatory authorities for a potential label expansion.
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