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Johnson & Johnson's AKEEGA® (niraparib and abiraterone acetate dual-action tablet) is the first PARP inhibitor combo to show improved efficacy in patients with HRR-mutated mHSPC vs. current standard of care

1. Johnson & Johnson's AMPLITUDE trial shows promising results in prostate cancer treatment. 2. Combination therapy reduced disease progression by nearly 50% in BRCA-altered patients. 3. Early data suggests improved overall survival with niraparib and abiraterone acetate. 4. Study reinforces biomarker-driven approach for aggressive cancer treatment strategies. 5. Safety profile consistent with past studies, despite increased adverse events.

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Why Bullish?

The promising Phase 3 results may enhance JNJ's competitive position in oncology. Historical examples show that positive trial results often correlate with stock price increases.

How important is it?

The article presents crucial advancements in JNJ's oncology portfolio, likely influencing investor sentiment and expectations.

Why Long Term?

Long-term impact expected as the market absorbs these developments and they translate into sales. Oncology drug successes can significantly influence long-term revenue growth.

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Results from the Phase 3 AMPLITUDE study show the potential of niraparib and abiraterone acetate to delay cancer progression and worsening of symptoms1 Data show a nearly 50 percent reduction in disease progression in BRCA-altered mHSPC1 BEERSE, BELGIUM, June 03, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson announced today first results from the Phase 3, randomised, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair (HRR) genetic alterations including BRCA.1 The results show a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS) – highlighting the potential of the combination in this patient population to delay both cancer progression and the worsening of symptoms.1 This marks the first Phase 3 data to show clinical improvement with a poly (ADP-ribose) polymerase (PARP) inhibitor-based combination in mHSPC.1 The findings are being presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology Annual Meeting.1 The data have also been selected for Best of ASCO and included in the ASCO Press Programme.1 “Approximately 25 percent of patients with mHSPC have HRR alterations, with about half being BRCA. These patients typically experience faster disease progression and poorer outcomes,” said Gerhardt Attard*, M.D., Ph.D., FRCP, John Black Charitable Foundation Chair of Medical Oncology, University College London Cancer Institute, Research Department of Oncology and presenting author. “The AMPLITUDE trial is the first to show that combining a PARP inhibitor with an androgen receptor pathway inhibitor both delays disease progression and postpones the onset of symptoms in HRR-altered mHSPC, supporting this combination as a new treatment option for these patients.” "Our aim with the AMPLITUDE study was to determine how long patients could live without their cancer worsening. What we found is that the combination of niraparib, abiraterone acetate, and prednisone is achieving just that, with the goal of offering patients precious quality time before the disease enters a more resistant phase,” said Charles Drake, M.D., Ph.D., FAAP, Vice President, Prostate Cancer and Immunotherapy Disease Area Leader, at Johnson & Johnson Innovative Medicine. “This breakthrough highlights the need for early initiation of personalised treatment strategies for patients with mHSPC and HRR alterations, particularly BRCA, who typically face more aggressive disease.” The Phase 3 AMPLITUDE study of 696 patients with mHSPC and HRR alterations met its primary endpoint of rPFS.1 Patients with BRCA alterations (n=191) showed the greatest benefit of treatment with the combination of niraparib plus AAP, as the median rPFS was not reached compared to 26 months in patients treated with the placebo plus AAP, reducing the risk of radiographic progression or death by 48 percent (hazard ratio [HR] 0.52, 95 percent confidence interval [CI], 0.37-0.72, p<0.0001).1 In patients with any HRR alteration treated with the niraparib combination, median rPFS was also not reached in comparison to 29.5 months in patients treated with the placebo plus AAP, with a reduction in risk by 37 percent (HR 0.63, 95 percent CI, 0.49-0.80, p=0.0001).1 These results also showed that treatment with the niraparib combination reduced the risk of symptomatic progression by 56 percent in patients with BRCA alterations specifically (HR 0.44, 95 percent CI, 0.29-0.68, p=0.0001) and 50 percent in all patients harbouring HRR alterations (HR 0.50, 95 percent CI, 0.36-0.69, p<0.0001), meaning that patients experienced a longer delay to worsening symptoms and requiring radiation, surgical intervention, or needing a new anti-cancer therapy.1 The first interim analysis showed an early trend toward improved overall survival (OS) favouring the niraparib/AAP combination with a reduction in risk of death of 25 percent (HR 0.75, 95 percent CI, 0.51-1.11, p=0.15) in patients with BRCA alterations and 21 percent in all those with HRR alterations (HR 0.79, 95 percent CI, 0.59-1.04, p=0.10).1 Follow-up is ongoing for maturity of the data.2 Grade 3/4 adverse events (AEs) were more frequent with the niraparib combination compared to the placebo group (75 percent vs. 59 percent), with anaemia and hypertension being the most common; however, treatment discontinuations due to AEs remained low (14.7 percent vs. 10.3 percent).1 To date, the safety profile of niraparib plus abiraterone acetate and prednisone has been consistent with prior experiences in patients with metastatic castration-resistant prostate cancer (mCRPC).1 “The AMPLITUDE study reinforces the power of a biomarker-driven approach and the potential of this novel combination regimen to shift the treatment paradigm in prostate cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “By identifying patients most likely to benefit from targeted therapy early in their treatment journey, we have an opportunity to improve clinical and quality of life outcomes and delay progression to more advanced stages." New data from the CAPTURE study (Abstract #5094), also being presented at the 2025 ASCO Annual Meeting with simultaneous publication in the Annals of Oncology, reinforce that the presence of HRR, specifically BRCA alterations, among patients with mHSPC are associated with significantly worse prognosis.3 Despite the availability of life-prolonging androgen receptor pathway (ARP) inhibitors, patients with HRR-altered mHSPC experience approximately 30 percent faster disease progression and shorter survival, while patients with BRCA-altered mHSPC experience approximately 50 percent faster disease progression and shorter survival – highlighting the importance of genetic testing to inform treatment decisions and the urgent need for novel targeted therapies to improve outcomes and delay progression.4 With the AMPLITUDE study, Johnson & Johnson becomes the first to show that a PARP inhibitor combination can benefit patients with mHSPC.1,5 ____________________ About AMPLITUDEAMPLITUDE (NCT04497844) is an ongoing, Phase 3, randomised, double-blind, placebo-controlled, international study evaluating the efficacy and safety of niraparib and abiraterone acetate in a dual-action tablet (DAT) formulation with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate with prednisone plus ADT in patients with deleterious germline or somatic homologous recombination repair (HRR) gene-altered metastatic hormone-sensitive prostate cancer (mHSPC).2 The primary endpoint is radiographic progression-free survival (rPFS).2 About Metastatic Hormone-Sensitive Prostate CancerMetastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to ADT and has spread to other parts of the body.6 About Niraparib and Abiraterone AcetateThis orally administered, dual-action tablet (DAT) consists of a combination of niraparib, a highly selective poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor.2,7 Niraparib combined with abiraterone acetate with prednisone or prednisolone was approved in April 2023 by the European Commission for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).8 In this indication, it is available in two dose strengths: regular-strength (100 mg niraparib/500 mg AA) and low-strength (50 mg niraparib/500 mg AA).7 The recommended dose is 200 mg niraparib and 1,000 mg AA daily.7 Additional marketing authorisation applications are under review across a number of countries globally. In April 2016, Janssen Biotech, Inc. entered into a worldwide (except Japan) collaboration and license agreement with TESARO, Inc. (acquired by GSK in 2019), for exclusive rights to niraparib in prostate cancer.9 About Johnson & JohnsonAt 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. Janssen-Cilag International NV, Janssen Biotech, Inc., and Janssen-Cilag, S.A. are Johnson & Johnson companies. Cautions Concerning Forward-Looking StatementsThis 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 impacts of niraparib and abiraterone acetate. 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.     © Janssen-Cilag International NV, Inc. 2025. All rights reserved.    *Dr. Attard has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Attard G et al. Phase 3 AMPLITUDE trial: niraparib and abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer patients with alterations in homologous recombination repair genes. 2025 American Society of Clinical Oncology Annual Meeting. 3 June 2025.2 Clinicaltrials.gov. A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE). Available at: https://clinicaltrials.gov/study/NCT04497844. Last accessed May 2025.3 Olmos D et al. BRCA1/2 and HRR alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.4 Olmos D et al. BRCA1/2 and homologous recombination repair alterations in high- and low-volume metastatic hormone-sensitive prostate cancer: prevalence and impact on outcomes. Annals of Oncology, 2 June 2025. DOI: 10.1016/j.annonc.2025.05.534. 5 Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12. PMID: 30987939.6 National Cancer Institute. Hormone-sensitive prostate cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/hormone-sensitive-prostate-cancer. Accessed May 2025.7 AKEEGA Summary of Product Characteristics. August 2024. Available at: https://www.ema.europa.eu/en/documents/product-information/akeega-epar-product-information_en.pdf. Last accessed May 2025.8 Janssen EMEA. Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations. Available at: https://innovativemedicine.jnj.com/emea/janssen-marks-first-approval-worldwide-akeegar-niraparib-and-abiraterone-acetate-dual-action-tablet. Last accessed May 2025.9 Johnsonandjohnson.gcs-web.com. Janssen Enters Worldwide Collaboration and License Agreement with TESARO, Inc., for Niraparib in Prostate Cancer. Available at: https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/janssen-enters-worldwide-collaboration-and-license-agreement. Accessed May 2025. CP-523901May 2025

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