ERLEADA (apalutamide) - (PROTEUS)

May 31, 2026: Johnson & Johnson (NYSE: JNJ) reported final Phase 3 PROTEUS results for perioperative apalutamide (ERLEADA) plus androgen deprivation therapy (ADT) given for six months before and after radical prostatectomy in newly diagnosed high-risk localized or locally advanced prostate cancer (n=2,109). The study met both dual primary endpoints (pCR/minimal residual disease and metastasis-free survival) by blinded independent central review at a median follow-up of 61.7 months.

Key efficacy: pCR/MRD was 8.9% with apalutamide+ADT vs 1.0% with ADT alone (OR 10.17; 95% CI 5.27–19.64; p<0.0001). Metastasis-free survival improved with a 20% reduction in risk of metastasis or death (HR 0.80; 95% CI 0.67–0.96; p=0.02; 5-year 78.2% vs 73.5%). Time to subsequent therapy was 74.2 vs 41.5 months (HR 0.65; p<0.0001). Event-free survival and time to distant metastasis also improved.

Safety: Grade 3/4 AEs were 39.6% vs 31.0%; discontinuations 7.4% vs 2.7%; rash higher with apalutamide.

Catalyst: Data selected for ASCO 2026 plenary (LBA1) and published in The New England Journal of Medicine; regimen not yet approved in this setting, with additional analyses ongoing.