Johnson & Johnson - Phase 2 data for ERLEADA plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate

SAN ANTONIO - 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

'Despite treatment advancements over the last decade, half of patients with high-risk localized prostate cancer experience disease recurrence less than two years after radical prostatectomy, highlighting a need for treatment options that reduce longer-term risks,' said Luca Dezzani, M.D., Vice President, Medical Affairs, Solid Tumor, Johnson & Johnson Innovative Medicine. 'Studies like Apa-RP coupled with the continued evaluation of ERLEADA in ongoing Phase 3 studies are critical steps in understanding the full potential of earlier treatment intervention, with the ultimate goal of improving patient outcomes.'

Approximately 300,000 people are diagnosed with prostate cancer each year in the U.S.2 Up to 40% of patients will be classified as high-risk.3 Despite advancements in treatment, disease recurrence remains substantial; up to 50% of patients within ten years of surgery experience recurrence and carry a significant risk of disease progression and death.4

About Apa-RP

The Phase 2 multicenter, open-label single-arm study (NCT04523207) evaluated 108 patients across 32 U.S. community urologic practices. Patients were treatment-naive with HRLPC who had undergone RP and were treated with ERLEADA (240 mg, once daily) for 12 cycles (1 cycle = 28 days) and ADT for 12 months. The primary endpoint evaluated BCR-free rate, defined as two sequential prostate-specific antigen (PSA) levels of