Johnson & Johnson reported new Phase 3 results showing that an apalutamide-based treatment regimen significantly improved outcomes for patients with high-risk localized or locally advanced prostate cancer.
The study evaluated apalutamide, marketed as Erleada, combined with androgen-deprivation therapy for six months before and six months after radical prostatectomy.
Compared with immediate surgery alone, the regimen produced a 62% reduction in the estimated risk of biochemical recurrence or death, according to the company.
The study also showed a 51% reduction in the estimated risk of metastasis or death over time.
At three years, twice as many patients receiving perioperative apalutamide plus hormone therapy remained free from subsequent treatment compared with patients undergoing surgery alone.
The results come from a substudy of the Phase 3 PROTEUS program.
The findings are important because patients with high-risk localized prostate cancer can face recurrence even after surgery intended to remove the disease.
Using systemic therapy around surgery could potentially reduce that risk by attacking cancer cells before and after the procedure.
The results do not by themselves establish a new standard of care.
Regulatory review, complete study analysis and clinical evaluation will determine how the regimen may ultimately be used.
For Johnson & Johnson, the data could strengthen the company’s prostate-cancer franchise while potentially expanding the role of apalutamide into an earlier stage of disease treatment.
Investors and physicians will now watch additional PROTEUS data, regulatory discussions and whether the benefit remains durable over longer follow-up.
