Johnson & Johnson's Perioperative ERLEADA Regimen Cuts Recurrence or Death Risk 62% Versus Surgery Alone

Johnson & Johnson said on October 24, 2026 that a Phase 3 PROTEUS substudy of ERLEADA (apalutamide) plus androgen deprivation therapy given before and after surgery reduced the risk of disease recurrence or death by 62 percent compared with radical prostatectomy alone in patients with high-risk localized or locally advanced prostate cancer. The results were announced by PR Newswire.

Inside the PROTEUS Substudy Results

The substudy evaluated apalutamide plus ADT before and after surgery against radical prostatectomy alone in 408 patients with newly diagnosed, non-metastatic, high-risk localized or locally advanced prostate cancer who were fit for surgery and systemic therapy. The primary endpoint was event-free survival, defined as the time to biochemical failure, local or regional recurrence, distant metastasis or death.

At a median follow-up of 37.8 months, apalutamide plus ADT significantly improved event-free survival, reducing the risk of recurrence or death by 62 percent compared with surgery alone, with a hazard ratio of 0.38 and a 95 percent confidence interval of 0.26 to 0.55. Median event-free survival was not reached with apalutamide plus ADT, compared with 19.1 months with surgery alone. At three years, 63 percent of patients receiving apalutamide plus ADT remained event-free compared with 41.4 percent of those undergoing surgery alone.

For the secondary endpoint of metastasis-free survival, apalutamide plus ADT showed a 51 percent lower risk of distant metastasis or death, with a hazard ratio of 0.49 and a 95 percent confidence interval of 0.26 to 0.90. For the exploratory endpoint of time to first subsequent therapy, the regimen showed a 71 percent lower risk of needing subsequent treatment, with a hazard ratio of 0.29 and a 95 percent confidence interval of 0.20 to 0.43. At three years, 64.6 percent of patients receiving apalutamide plus ADT remained free from subsequent therapy compared with 32 percent undergoing surgery alone.

Grade 3 or 4 treatment-emergent adverse events occurred in 31 percent of patients receiving apalutamide plus ADT and 22 percent receiving surgery alone. No treatment-emergent adverse events leading to death were reported in either arm. The most common adverse events with apalutamide included hot flush (64 percent) and urinary incontinence (63 percent).

"The primary PROTEUS study showed the potential of treating high-risk prostate cancer earlier with apalutamide plus androgen deprivation therapy. We designed this substudy to take that evidence further by evaluating the regimen against surgery alone, a longstanding standard of care for these patients," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson.

Johnson & Johnson's Prostate Cancer Deal History

Johnson & Johnson Services, Inc. acquired Halda Therapeutics for $3.05 billion in November 2025 to add RIPTAC therapies and the HLD-0915 candidate targeting metastatic castration-resistant prostate cancer, according to akta.pro company records. The company also acquired Firefly Bio for approximately $1 billion in June 2026 to gain degrader antibody conjugate technology targeting KRAS-driven tumors. Johnson & Johnson reported FY2025 revenue of $94.2 billion with 6 percent growth and net income of $26.8 billion.

Earlier Prostate Cancer Data at ESMO 2026

On October 24, 2026, Johnson & Johnson said its experimental prostate cancer drug caused tumors to shrink or disappear in an early-stage trial, with PSA levels falling by at least 50 percent in 77 percent of 31 evaluable patients and 69 percent of patients with measurable tumors showing a confirmed response, according to Yahoo. On October 23, 2026, the company said it will present first clinical data for prostate cancer drug JNJ-6143 at ESMO 2026, including safety and efficacy findings, according to The future of trading.

What Comes Next for the PROTEUS Program

Additional follow-up is underway to evaluate overall survival. The new results were presented as a late-breaking abstract at the European Society for Medical Oncology Congress 2026, and the accompanying manuscript has been accepted for publication by European Urology.