Study highlights opportunity for treatment intensification in this population since approximately 50 percent of patients with high-risk localised prostate cancer (HRLPC) experience disease recurrence within two years of surgery1
BEERSE, BELGIUM, May 03, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, 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 percent biochemical recurrence (BCR)-free rate at 24 months.1 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.1
“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 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 percent, confidence interval [CI]: 93.0-100.0).1 The treatment regimen demonstrated a serum testosterone recovery (≥150 ng/dL) rate of 76.4 percent at 12 months (95 percent CI, 65.0 – 84.5).1 The safety profile of apalutamide with ADT was consistent with previous reports: treatment emergent adverse events (TEAEs) were reported by 99.1 percent of patients; 22.2 percent of TEAEs were Grade 3-4.1
“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, M.D., 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.2 Despite advancements in treatment, disease recurrence remains substantial; up to 50 percent of patients within ten years of surgery experience recurrence and carry a significant risk of disease progression and death.3
“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."
#ENDS#
About Apa-RP
The Phase 2 multicentre, open-label single-arm study (NCT04523207) evaluated 108 patients across 32 U.S. community urologic practices.4 Patients were treatment-naïve with high-risk localised prostate cancer who had undergone radical prostatectomy and were treated with apalutamide (240 mg, once daily) for 12 cycles (1 cycle = 28 days) and androgen deprivation therapy for 12 months.5 The primary endpoint evaluated BCR-free rate, defined as two sequential prostate-specific antigen (PSA) levels 0.2 ng/ mL.5 The secondary endpoints included testosterone recovery rate and safety.5
About Apalutamide
Apalutamide is an is an orally administered, selective androgen receptor (AR) inhibitor approved in the following indications in Europe:
- in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease,5 and;
- in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).6
Additional studies are ongoing in the evaluation of apalutamide for the treatment of localised high-risk or locally advanced prostate cancer including the Phase 3 ATLAS (NCT02531516) and PROTEUS (NCT03767244) studies.6,7
▼ In line with EMA regulations for new medicines, apalutamide is subject to additional monitoring.
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. Follow us at https://twitter.com/JNJInnovMedEMEA and https://www.linkedin.com/company/jnj-innovative-medicine-emea for our latest news. Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & Development, LLC are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of apalutamide. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & & Development, LLC and Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Pharmaceutica NV, and Janssen Research & Development, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
© Janssen-Cilag International NV, Inc. 2024. All rights reserved.
*Dr. Shore, M.D., F.A.C.S has not been paid for any media work.
References
1 Shore N, et al. Apalutamide and androgen deprivation therapy for the treatment of high-risk localized prostate cancer following radical prostatectomy in Apa-RP: a multicenter, open-lable, single-arm Phase 2 study. Oral Presentation, 2024 American Urological Association Annual Meeting. May 2024.
2 GLOBOCAN 2022. Europe Cancer Factsheet 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. Last accessed May 2024.
3 Napodano G, et al. High-Risk Prostate Cancer: A Very Challenging Disease in the Field of Uro-Oncology. Diagnostics (Basel). 2021 Feb 26;11(3):400. doi: 10.3390/diagnostics11030400. PMID: 33652852; PMCID: PMC7996958.
4 ClinicalTrials.gov. A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases. Available at: https://clinicaltrials.gov/study/NCT04523207. Last accessed May 2024.
5 European Medicines Agency. ERLEADA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/productinformation/erleada-epar-product-information_en.pdf. Last accessed May 2024.
6 ClinicalTrials.gov. An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS. Available at: https://clinicaltrials.gov/study/NCT02531516. Last accessed May 2024.
7 ClinicalTrials.gov. A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy (PROTEUS). Available at: https://clinicaltrials.gov/study/NCT03767244. Last accessed May 2024.
May 2024
CP-449917
