Johnson & Johnson says perioperative apalutamide cut recurrence or death risk 62%

Johnson & Johnson said new results from the Phase 3 PROTEUS substudy show that giving apalutamide plus androgen deprivation therapy (ADT) for six months before and after surgery cut the risk of disease recurrence or death by 62% compared with radical prostatectomy alone. The patients had high-risk localized or locally advanced prostate cancer. The regimen is investigational. The company announced the results on October 24, 2026.

The substudy enrolled 408 patients, of whom 102 received apalutamide plus ADT and 306 underwent radical prostatectomy alone. At a median follow-up of 37.8 months, median event-free survival was not reached with apalutamide plus ADT, compared with 19.1 months with surgery alone. At three years, 63% of patients on the regimen remained event-free, compared with 41.4% after surgery alone.

For metastasis-free survival, a secondary endpoint, the company said the regimen showed a numerical improvement, with a 51% lower risk of distant metastasis or death (nominal p=0.0193). On an exploratory endpoint, time to first subsequent therapy, the regimen showed a 71% lower risk of needing subsequent treatment. At three years, 64.6% of patients remained free from subsequent therapy, compared with 32% after surgery alone.

Grade 3 or 4 treatment-emergent adverse events occurred in 31% of patients receiving apalutamide plus ADT and 22% of those receiving surgery alone. No treatment-emergent adverse events leading to death were reported in either arm.

The new results were presented as a late-breaking abstract at the European Society for Medical Oncology (ESMO) Congress 2026, and the accompanying manuscript has been accepted for publication by European Urology. Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson, said the substudy was designed to evaluate the regimen against surgery alone. Apalutamide plus ADT has not been approved by regulators for this use.