Headline : Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery

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Study highlights opportunity for treatment intensification in this population since approximately 50% of patients with high-risk localized prostate cancer (HRLPC) experience disease recurrence within two years of surgery

SAN ANTONIO, May 3, 2024 /PRNewswire/ -- Johnson & Johnson announced today results from the open-label, single-arm Phase 2 Apa-RP study evaluating adjuvant treatment with ERLEADA® (apalutamide) and androgen deprivation therapy (ADT) in patients with HRLPC who have undergone radical prostatectomy (RP). Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)–free rate at 24 months.1 These data were presented today at an Oral Presentation Session (Abstract #P2-07) at the 2024 American Urological Association Annual Meeting AUA, May 3-6, 2024, in San Antonio, Texas. 

"Findings from the Apa-RP study support the benefit of treatment intensification with apalutamide and androgen deprivation therapy following radical prostatectomy for patients who are at high risk for BCR and thus progression to metastatic prostate cancer," said Neal Shore, M.D., F.A.C.S., Steering Committee Chair and Chief Medical Officer, Surgical Oncology and Urology, Genesis Care.* "Results from this study encourage additional research for high-risk localized prostate cancer and highlight the promise of bringing treatment into earlier stages of disease following radical prostatectomy."

The study met its primary endpoint, showing that patients who received 12 months of ERLEADA® plus ADT adjuvant to RP experienced no confirmed biochemical recurrence after 12 additional months of follow-up. The treatment regimen demonstrated a serum testosterone recovery (≥150 ng/dL) rate of 76.4% at 12 months (95% CI, 65.0–84.5). The safety profile of ERLEADA® with ADT was consistent with previous reports: treatment-emergent adverse events (TEAEs) were reported by 99.1% of patients; 22.2% of TEAEs were grade 3-4.1

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