Johnson & Johnson announces ERLEADA® (apalutamide) treatment before and after surgery reduces risk of recurrence or death by 62% versus surgery alone in high-risk localised or locally advanced prostate cancer

• New substudy results showed a 51% lower estimated risk of metastasis or death over time with perioperative apalutamide plus hormone therapy compared with immediate surgery1

• Twice as many patients remained free from subsequent treatment at three years with perioperative apalutamide plus hormone therapy compared with surgery alone1

• Results evaluated outcomes versus surgery alone, building on the primary results presented at ASCO 20261

BEERSE, BELGIUM , Oct. 24, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new results from the Phase 3 PROTEUS substudy that directly compared the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy), given for six months before and after surgery, with radical prostatectomy alone in patients with high-risk localised or locally advanced prostate cancer.1 The apalutamide plus hormone therapy regimen reduced the risk of disease recurrence or death by 62% compared with surgery alone.1 The regimen also showed a nominal improvement in metastasis-free survival (MFS), with a 51% lower risk of metastasis or death.1 Patients receiving perioperative treatment also experienced longer time to subsequent therapy compared with surgery alone.1

These substudy findings build on the primary PROTEUS results presented during the plenary session of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, and evaluate a remaining clinical question by directly comparing perioperative apalutamide plus hormone therapy with surgery alone, a longstanding standard of care.1,2,3

The new results were presented as a late-breaking abstract in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2026 (#LBA53).1 The accompanying manuscript has been accepted for publication by European Urology.

For patients with high-risk localised or locally advanced prostate cancer, surgery has long been a standard of care performed with curative intent.4,5 Yet nearly half of patients will see their cancer return and require additional treatment.6,7 Recurrence can mean facing further therapy and the continued risk that the disease will spread, underscoring the need for approaches that can improve outcomes earlier in the course of disease.8

Apalutamide blocks androgen hormones from binding to their receptor, which can help slow prostate cancer progression.9

“Radical prostatectomy has long been a cornerstone of curative-intent treatment for high-risk localised prostate cancer, yet recurrence remains a concern for patients with aggressive disease,” said Alberto Briganti,* M.D., Professor of Urology and Urologic Surgeon at IRCCS San Raffaele Hospital, Milan. “In this substudy, median event-free survival was 19.1 months with surgery alone, highlighting the challenges these patients continue to face despite treatment intended to cure their cancer. The reduction in the risk of recurrence and metastases after radical prostatectomy seen with apalutamide plus androgen deprivation therapy suggests we may be able to build on surgery and help more patients achieve lasting disease control.”

“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. “These findings provide important additional insight into what this approach could mean for patients and reinforce why we continue to investigate ways to improve outcomes earlier in the course of disease.”

“Patients with high-risk prostate cancer deserve the best possible chance of remaining free from their disease for the long term,” said Henar Hevia, Ph.D., EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. “The PROTEUS results build on the progress we have made in prostate cancer and reinforce the importance of continuing to challenge what is possible for patients facing a high risk of recurrence. We want to keep raising expectations for what treatment can achieve, so that more patients can look to the future with greater confidence.”

The PROTEUS substudy evaluated apalutamide plus hormone therapy before and after surgery compared with radical prostatectomy alone in 408 patients with newly diagnosed, non-metastatic, high-risk localised or locally advanced prostate cancer who were fit for surgery and systemic therapy.1 The primary endpoint was event-free survival (EFS), defined as the time to biochemical failure, local or regional recurrence, distant metastasis or death.1

At a median follow-up of 37.8 months, apalutamide plus hormone therapy significantly improved EFS, reducing the risk of recurrence or death by 62% compared with surgery alone (hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.26-0.55; p<0.0001).1 Median EFS was not reached with apalutamide plus hormone therapy, compared with 19.1 months with surgery alone.1 At three years, 63% of patients receiving apalutamide plus hormone therapy remained event-free compared with 41.4% of those undergoing surgery alone.1

Nominal improvements were also observed across secondary and exploratory endpoints.1 For the secondary endpoint of MFS, apalutamide plus hormone therapy showed a 51% lower risk of distant metastasis or death (HR, 0.49; 95% CI, 0.26-0.90; nominal p=0.0193).1 For the exploratory endpoint of time to first subsequent therapy, the regimen showed a 71% lower risk of needing subsequent treatment (HR, 0.29; 95% CI, 0.20-0.43; nominal p<0.0001).1 At three years, 64.6% of patients receiving apalutamide plus hormone therapy remained free from subsequent therapy compared with 32% undergoing surgery alone.1 Additional follow-up is underway to evaluate overall survival.1

The safety profile was consistent with the primary PROTEUS study results. Grade 3 or 4 treatment-emergent adverse events occurred in 31% of patients receiving apalutamide plus hormone therapy and 22% receiving surgery alone.1 No treatment-emergent adverse events leading to death were reported in either arm. The most common adverse events with apalutamide included hot flush (64%) and urinary incontinence (63%).1

Apalutamide plus hormone therapy has not been approved by regulatory authorities for the treatment of high-risk localised or locally advanced prostate cancer. These findings add to the growing body of evidence evaluating the potential of treating selected patients with high-risk prostate cancer earlier in the course of disease.

The PROTEUS substudy (NCT03767244) is a randomised, open-label study evaluating perioperative apalutamide plus androgen deprivation therapy (ADT) compared with radical prostatectomy alone in patients with high-risk localised or locally advanced prostate cancer who are candidates for radical prostatectomy.1,10 The substudy was designed to further evaluate the efficacy and safety of adding apalutamide plus ADT before and after surgery compared with surgery alone.1,10

A total of 408 patients were randomised to one of two treatment groups, with 102 receiving apalutamide plus ADT and 306 undergoing radical prostatectomy alone.1,10 Patients receiving apalutamide plus ADT were treated for six 28-day cycles before radical prostatectomy with pelvic lymph node dissection and for six cycles after surgery, with apalutamide paused two weeks before and resumed four weeks after radical prostatectomy with pelvic lymph node dissection.1,10 Apalutamide was administered orally at 240 mg once daily.1,10 Patients in the comparator arm underwent radical prostatectomy with pelvic lymph node dissection followed by standard institutional practice or observation.1,8

The primary endpoint is event-free survival (EFS), defined as the time to biochemical failure, local or regional recurrence, distant metastasis or death.1,10 Secondary endpoints include prostate-specific antigen (PSA)-free survival and metastasis-free survival (MFS), with exploratory endpoints including time to first subsequent systemic therapy and overall survival.1,8

Approximately 462,000 men were diagnosed with prostate cancer across Europe in 2024, making it the most commonly diagnosed cancer among European men.11 An estimated 15% of patients present with high-risk disease at diagnosis.12,13 Patients with high-risk localised or locally advanced prostate cancer remain at substantial risk of biochemical recurrence following radical prostatectomy, with reports of biochemical progression rates exceeding 50% at five years.13

About Apalutamide

Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor. The European Commission (EC) has previously approved apalutamide in the following indications in Europe:9

• in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.99

• in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).9

An additional Phase 3 study, ATLAS (NCT02531516), is ongoing, evaluating apalutamide in combination with radiotherapy in patients with localised high-risk or locally advanced prostate cancer.14 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using apalutamide, please refer to the Summary of Product Characteristics.9

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://innovativemedicine.jnj.com/emea/. Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea/.

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 materialise, actual results could vary materially from the expectations and projections of 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 behaviour 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 most recent Annual Report on Form 10-K, 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 http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

*Prof. Alberto Briganti has served as a consultant to Johnson & Johnson; he has not been paid for any media work.

1 Briganti, A. et al. A PROTEUS substudy of perioperative apalutamide (APA) plus androgen deprivation therapy (ADT) with radical prostatectomy plus pelvic lymph node dissection (RP + PLND) vs RP + PLND alone in patients (pts) with high-risk localized or locally advanced prostate cancer (HR LPC/LAPC). Presented at: European Society for Medical Oncology (ESMO) 2026 Congress; October 24, 2026; Madrid. 2 Taplin ME et al. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 Aug 6;395(6):546-560. doi: 10.1056/NEJMoa2603878. 3 Taplin, M. et al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. Presented at: American Society of Clinical Oncology (ASCO) 2026 Congress; May 31, 2026; Chicago. 4 Qi R, Moul J. High-Risk Prostate Cancer: Role of Radical Prostatectomy and Radiation Therapy. Oncol Res Treat. 2015;38(12): 639-644. 5 Wenzel M, et al. Radical Prostatectomy Versus Radiation Therapy for Locally Advanced and Clinically Nodal Positive Prostate Cancer. Clin Genitourin Cancer. 2025;23(4):102370. 6 Eiber M, et al. PHAROS, a real-world multi-country European study on patients with high-risk localised and locally advanced prostate cancer receiving radical treatment. J Clin Oncol. 2024;42:5024. 7 Stattin P, et al. Population-based study of disease trajectory after radical treatment for high-risk prostate cancer. BJU Int. 2024;134:96-102. 8 Migliaccio F, et al. Salvage radiotherapy with or without hormonal therapy for biochemical recurrence after radical prostatectomy: A systematic review and meta-analysis. Prostate Cancer Prostatic Dis. 2026. 9 European Medicines Agency. ERLEADA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf. Accessed October 2026. 10 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. Accessed October 2026. 11 Globocan. Europe Fact Sheet, Prostate Cancer, 2024. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. Accessed October 2026. 12 Reina Y, Villaquirán C, García-Perdomo HA. Advances in high-risk localized prostate cancer: Staging and management. Current Problems in Cancer. 2023;47(5):100993. 13 Wani M, et al. What Is New in the Management of High-Risk Localized Prostate Cancer? Cancers (Basel). 2022;14(23):5861. 14 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. Accessed October 2026.

CP-607573 October 2026