Johnson & Johnson announced results from the open-label, single-arm Phase 2 Apa-RP study evaluating adjuvant treatment with ERLEADA (apalutamide) and androgen deprivation therapy (ADT) in patients with HRLPC who have undergone radical prostatectomy (RP). Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)?free rate at 24 months. These data were presented at an Oral Presentation Session (Abstract #P2-07) at the 2024 American Urological Association Annual Meeting AUA, May 3-6, 2024, in San Antonio, Texas. The study met its primary endpoint, showing that patients who received 12 months of ERLEADA plus ADT adjuvant to RP experienced no confirmed biochemical recurrence after 12 additional months of follow-up.

The treatment regimen demonstrated a serum testosterone recovery (=150 ng/dL) rate of 76.4% at 12 months (95% CI, 65.0?84.5). The safety profile of ERLEADA with ADT was consistent with previous reports: treatment-emergent adverse events (TEAEs) were reported by 99.1% of patients; 22.2% of TEAEs were grade 3-4.