(RTTNews) - Johnson & Johnson (JNJ) revealed findings from the final analysis of the Phase 3 PROTEUS study assessing apalutamide plus hormone therapy (androgen deprivation therapy, ADT) administered for six months before and after prostate cancer surgery. The investigational approach delivered meaningful gains for patients with high-risk localized or locally advanced disease.

The trial achieved both primary endpoints. Individuals receiving apalutamide plus hormone therapy proved nine times more likely to show little or no remaining cancer at surgery than those on hormone therapy alone (8.9% versus 1.0%). The combination lowered the risk of metastasis or death by 20% and pushed the interval before further therapy beyond six years.

With median follow-up reaching 61.7 months, apalutamide plus hormone therapy produced a statistically significant advantage. Pathologic complete response or minimal residual disease occurred in 8.9% of patients versus 1.0% with hormone therapy alone. Metastasis-free survival improved with a hazard ratio of 0.80, yielding five-year rates of 78.2% versus 73.5%. Investigator reviews aligned with these outcomes.

Key secondary measures supported the regimen's value. Patients given one year of apalutamide plus hormone therapy before and after surgery waited more than six years for subsequent therapy, versus roughly three and a half years with hormone therapy alone. Additional gains included a 29% drop in recurrence or death risk, extended time to distant metastasis, and stronger responses by residual cancer burden. Most patients regained adequate testosterone levels within 8.1 months.

The safety profile of apalutamide plus hormone therapy matched prior trials, underscoring its promise in reshaping care for high-risk localized and locally advanced prostate cancer.

For More Such Health News, visit rttnews.com

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.