J&J reports strong recurrence-risk reduction with perioperative ERLEADA in high-risk prostate cancer
Johnson & Johnson said a Phase 3 substudy found that giving ERLEADA plus hormone therapy before and after surgery cut the risk of recurrence or death by 62% compared with surgery alone. At a median follow-up of about 38 months, median event-free survival was not reached for the regimen versus 19.1 months for surgery alone, and three-year event-free rates were 63% versus 41.4%. The regimen is not approved for this use, and overall survival data are still being collected.
The PROTEUS Phase 3 substudy randomized 408 people with high-risk localized or locally advanced prostate cancer. Participants received apalutamide with androgen deprivation before and after surgery; the comparison was immediate surgery. At a median 37.8 months, median event-free survival had not been reached for the perioperative group, versus 19.1 months for surgery alone.
Three-year event-free rates were 63% and 41.4%, respectively. Estimated metastasis-or-death risk was 51% lower (nominal p=0.0193), and subsequent-treatment risk was 71% lower. Grade 3/4 treatment-emergent adverse events occurred in 31% versus 22%, with no treatment-emergent deaths in either arm. Overall survival data remain pending, and the regimen is not approved for this use.
For patients with high-risk prostate cancer and their families, these results could eventually offer another way to reduce recurrence risk, but the regimen may also add preoperative and postoperative treatment burden and more grade 3/4 adverse events. Clinicians may weigh that tradeoff against still-maturing overall survival data. If regulators approve the approach, health systems and payers could face questions about access, cost, and how to identify patients most likely to benefit.