Johnson & Johnson (JNJ) announced results from the final analysis of the Phase 3 PROTEUS study, evaluating apalutamide plus hormone therapy (androgen deprivation therapy, ADT) given for six months before and after prostate cancer surgery. The investigational regimen significantly improved both short- and long-term outcomes for patients with high-risk localized or locally advanced disease.
The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at surgery compared with hormone therapy alone (8.9% vs. 1.0%). The combination also reduced the risk of metastasis or death by 20% and extended the time before patients required subsequent therapy to more than six years.
At a median follow-up of 61.7 months, apalutamide plus hormone therapy demonstrated a statistically significant benefit. Pathologic complete response/minimal residual disease (pCR/MRD) was achieved in 8.9% of patients versus 1.0% with hormone therapy alone. Metastasis-free survival (MFS) improved with a hazard ratio of 0.80, corresponding to five-year rates of 78.2% versus 73.5%. Investigator assessments confirmed similar results.
Key secondary endpoints reinforced the benefit of the combination. Patients receiving one year of apalutamide plus hormone therapy before and after surgery went more than six years before needing subsequent therapy, compared to about three and a half years with hormone therapy alone. Additional improvements included a 29% reduction in the risk of recurrence or death (event-free survival), longer time to distant metastasis, and deeper responses as measured by residual cancer burden. Most patients also recovered adequate testosterone levels within 8.1 months.
The safety profile of apalutamide plus hormone therapy was consistent with previous studies, supporting its potential role in reshaping treatment for high-risk localized and locally advanced prostate cancer.
For More Such Health News, visit rttnews.com
For comments and feedback contact: editorial@rttnews.com
Business News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.