Phase 2 data for ERLEADA ▼(apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localised prostate cancer shows 100% biochemical free recurrence rate more than two years post-surgery
May 3, 2024 – Drug Discovery, Pharmaceutical – Janssen, Johnson & Johnson, Johnson & Johnson Innovative Medicine, Prostate cancer
Study highlights opportunity for treatment intensification in this population since approximately 50% of patients with high-risk localised prostate cancer (HRLPC) experience disease recurrence within two years of surgery
3 May 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company, 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 high-risk localised prostate cancer (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. These data were presented today as an Oral Presentation Session (Abstract #P2-07) at the 2024 American Urological Association Annual Meeting (AUA) taking place 3-6 May 2024, in San Antonio, Texas, US.
“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 MD, FACS, Steering Committee chair and chief medical officer, Surgical Oncology and Urology, Genesis Care. “Results from this study encourage additional research for high-risk localised 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 apalutamide plus ADT adjuvant to RP (n=108) experienced no confirmed biochemical recurrence after 12 additional months of follow-up (90%, confidence interval [CI]: 93.0-100.0). 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 apalutamide 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.
“Despite treatment advancements over the last decade, half of patients with high-risk localised 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 MD, vice president, Medical Affairs, Solid Tumour, Johnson & Johnson Innovative Medicine. “Studies like Apa-RP, coupled with the continued evaluation of apalutamide 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.”
Prostate cancer is the most common cancer in men in Europe, with 473,011 diagnoses in 2022 across the region. 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.
“At Johnson & Johnson, we have a deep commitment to improving outcomes and redefining treatment standards for patients with prostate cancer at all stages of disease,” said Henar Hevia, senior director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “The results of this study offer a significant step towards enabling patients to benefit from transformative treatments in earlier stages of intervention and, ultimately, towards our goal of making prostate cancer a disease of the past.”
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/emea.
