Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm
Johnson & Johnson announced the results of the final analysis of the Phase 3 PROTEUS study, which showed that the investigational use of apalutamide combined with hormone therapy significantly improved clinical outcomes for patients with high-risk localized or locally advanced prostate cancer. The combination therapy was associated with a ninefold increase in the likelihood of patients having little to no cancer remaining at surgery compared to hormone therapy alone. Furthermore, this combination reduced the risk of developing metastasis or death by 20 percent and prolonged the time to subsequent therapy to over six years.
The findings are scheduled for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and will be published in The New England Journal of Medicine. The PROTEUS study enrolled 2,109 patients and evaluated the effect of apalutamide, an androgen receptor pathway inhibitor, administered before and after prostate cancer surgery.
Data from the study indicated that at a median follow-up of 61.7 months, the rate of pathologic complete response or minimal residual disease was 8.9 percent in the group receiving apalutamide plus hormone therapy compared to 1.0 percent in those receiving hormone therapy alone. A 20 percent reduction in the risk of metastasis or death was also observed, with a five-year survival rate of 78.2 percent versus 73.5 percent, respectively.
Mary-Ellen Taplin, principal investigator and medical oncologist at Dana-Farber Cancer Institute, commented, "The PROTEUS trial demonstrates that adding preoperative apalutamide to androgen deprivation therapy and surgery can substantially reduce the risk of metastasis or death, potentially improving cure rates and decreasing the need for subsequent therapies."
Despite these promising results, apalutamide plus hormone therapy has not yet received approval from regulatory authorities for this specific use. Ongoing studies will further evaluate its efficacy in comparison to current standard treatments for high-risk localized prostate cancer.