Johnson & Johnson’s Erleada combined with androgen deprivation therapy before and after surgery reduced the risk of recurrence or death by 62% versus surgery alone in a Phase 3 prostate cancer substudy.
The PROTEUS substudy included 408 patients with newly diagnosed, nonmetastatic, high-risk localized or locally advanced prostate cancer. Participants received apalutamide, marketed as Erleada, plus hormone therapy for six months before and six months after surgery, or underwent surgery alone.
After median follow-up of 37.8 months, the regimen significantly improved event-free survival, with a hazard ratio of 0.38 and a p-value below 0.0001.
The endpoint included biochemical failure, local or regional recurrence, distant metastasis or death. At three years, 63% of patients receiving the combination remained event-free, compared with 41.4% undergoing surgery alone.
Median event-free survival was not reached in the combination group, versus 19.1 months with surgery alone.
The regimen also showed a numerical 51% reduction in the risk of distant metastasis or death, a secondary endpoint with a nominal p-value of 0.0193.
At three years, 64.6% of combination recipients remained free from subsequent treatment, compared with 32% in the surgery-only group. Overall survival follow-up continues.
Grade 3 or 4 treatment-emergent adverse events occurred in 31% of combination recipients and 22% undergoing surgery alone. Neither group had treatment-emergent adverse events leading to death.
Hot flushes and urinary incontinence were the most common adverse events with apalutamide.
Apalutamide plus androgen deprivation therapy is not approved for high-risk localized or locally advanced prostate cancer. Erleada currently has approvals in advanced prostate cancer.
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