Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Apalutamide▼ and Abiraterone Acetate Combination
FOR EMEA-BASED PHARMACEUTICAL TRADE AND MEDICAL MEDIA ONLY
NOT FOR DISTRIBUTION IN THE UK, BENELUX
The Janssen Pharmaceutical Companies of Johnson & Johnson today presented results from the randomised, placebo-controlled double-blind Phase 3 ACIS study, which met the primary endpoint of radiographic progression-free survival (rPFS) with a 31 percent reduction in the risk of radiographic progression or death in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Patients in the trial received either a combination of apalutamide and abiraterone acetate plus prednisone (combination arm) or placebo and abiraterone acetate plus prednisone (control arm).1 Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Rapid Abstract Session: Prostate Cancer, February 11 06:45 AM-8:00 PM CET).
The primary efficacy analysis showed median rPFS was extended by six months in patients treated in the combination arm compared with patients in the control arm (22.6 vs 16.6 months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; p<0.0001). The HR for radiographic progression or death as assessed by blinded independent central review (BICR) was 0.864 [95% CI, 0.718–1.040]. According to an updated analysis performed at a median follow-up time of 54.8 months, a 30 percent reduction in the risk of radiographic progression or death was shown in the combination arm compared with the control arm (median time to rPFS 24 vs 16.6 months: HR 0.70 [95% CI, 0.60-0.83]). No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms.
The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the combination arm versus 56.2 percent in the control arm.1 Grade 3/4 TAEs that occurred more frequently in the combination versus control arm included fatigue (4.7 percent vs 3.9 percent), hypertension (20.6 versus 12.5 percent), fall (3.3 percent versus 0.6 percent), skin rash (4.5 percent vs. 0.4 percent), cardiac disorders (9 percent vs 5.7 percent), fractures and osteoporosis (4.1 percent vs 1.4 percent), and seizures (0.2 percent vs 0).1 Quality-of-life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate – (FACT-P Total).
##ENDS##
About the ACIS Study 1
ACIS is a Phase 3 randomised, double-blind, placebo-controlled, multicentre clinical study evaluating the efficacy and safety of apalutamide and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT.1 Patients were randomised to receive either apalutamide and abiraterone acetate plus prednisone, or placebo and abiraterone acetate plus prednisone. The primary endpoint of the study was rPFS. Secondary endpoints of the study included OS, time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.1
About Metastatic Castration-Resistant Prostate Cancer
Metastatic castration-resistant prostate cancer (mCRPC) characterises cancer that no longer responds to ADT and has spread to other parts of the body. The most common metastatic sites are bones, followed by lymph nodes, lungs, and liver.2 Prostate cancer is the most common cancer in men in Europe, representing 25 percent of all male new cancer cases diagnosed.3 More than one million men around the world are diagnosed with prostate cancer each year.4
About apalutamide
Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor approved in Europe and is indicated
- in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and
- in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), in combination with androgen deprivation therapy (ADT).5
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
About abiraterone acetate
Abiraterone acetate, an orally administered androgen biosynthesis inhibitor, in combination with prednisone or prednisolone is approved in Europe for
- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT);
- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated, and
- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.6
Additionally, abiraterone acetate was approved for the treatment of high-risk metastatic hormone-sensitive prostate cancer (mHSPC) by the U.S. Food and Drug Administration (FDA) on February 8, 2018.7,8 Since its first approval in Europe in 2011, abiraterone acetate has been approved in combination with prednisone or prednisolone, in more than 105 countries and has been prescribed to more than 700,000 patients worldwide.9
About The Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Date of preparation: February 2021
Job code: CP-209565
###
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential benefits and further benefits 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 Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or 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 Annual Report on Form 10-K for the fiscal year ended December 30, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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 the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References
1 Rathkopf. Dana E. Final Results From ACIS, a Randomized, Placebo (PBO)-Controlled Double-Blind Phase 3 Study of Apalutamide (APA) and Abiraterone Acetate Plus Prednisone (AAP) Versus AAP in Patients (Pts) With Chemo-Naive Metastatic Castration-Resistant Prostate Cancer (mCRPC). Abstract #9.
2 Cancer.org. Understanding advanced cancer, metastatic cancer, and bone metastasis. https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/what-is.html. Last accessed February 2021.
3 HEAL. Men Prostate cancer. Available https://www.env-health.org/IMG/pdf/prostate_testical.pdf Last accessed February 2021.
4 World Health Organization. "Globocan 2012: Prostate Cancer: Incidence, Mortality and Prevalence Worldwide, 2012." http://gco.iarc.fr/today/data/pdf/fact-sheets/cancers/cancer-fact-sheets-19.pdf. Accessed February 2021.
5 European Medicines Agency. ERLEADA. Available at: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_en.pdf. Last accessed February 2021.
6 European Medicines Agency. ZYTIGA. Available at: https://www.ema.europa.eu/en/documents/product-information/zytiga-epar-product-information_en.pdf, Last accessed February 2021.
7 ZYTIGA® U.S. Prescribing Information, October 2020.
8 Johnson & Johnson. Press Release. ZYTIGA® (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer. Available at: https://www.jnj.com/media-center/press-releases/zytiga-abiraterone-acetate-plus-prednisone-approved-for-treatment-of-earlier-form-of-metastatic-prostate-cancer. Last accessed January 2021
9 Data on file
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210209005604/en/
Contact information
Media Inquiries:
Alexandra Nisipeanu
Mobile: +40 744 383 413
Email: adridean@its.jnj.com
Noah Reymond
Mobile: +31 621 385 718
Email: nreymond@its.jnj.com
Investor Relations:
Christopher DelOrefice
Office: +1 732 524 2955
Jennifer McIntyre
Office: +1 732 524 3922
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Transition Industries Signs Strategic Agreements for the Pacifico Mexinol Project, the Largest Standalone Ultra-Low Carbon Chemical Production Facility in the World30.6.2025 21:30:00 EEST | Press release
Transition Industries LLC, a developer of world-scale, net-zero carbon emissions methanol and green hydrogen projects in North America, held a signing event for an Engineering, Procurement, and Construction (EPC) contract with the consortium of Samsung E&A Co., Ltd. (Samsung E&A), Grupo Samsung E&A Mexico, S.A. de C.V., and Techint Engineering and Construction for the Pacifico Mexinol project located in Ahome, Sinaloa, Mexico, which is contingent upon the fulfillment of customary conditions precedent and obtainment of all required approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630940954/en/ MAIRE group’s technology division NextChem, through its subsidiary KT TECH SpA, also signed a Basic Engineering, Critical and Proprietary Equipment Supply Agreement with Samsung E&A in connection with its proprietary NX AdWinMethanol®Zero technology supply to the project. Transition Industries is jointly developing the Pacif
Westinghouse and ITER Sign a $180M Contract to Advance Nuclear Fusion30.6.2025 16:45:00 EEST | Press release
Westinghouse Electric Company and ITER signed a contract for $180 million for the assembly of the vacuum vessel for the fusion reactor. This is a key milestone in the construction of the ITER reactor, leading the way toward the use of fusion as a practical future source of reliable carbon-free energy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630497810/en/ The ITER Tokamak pit with the two vacuum vessel sector modules installed. Westinghouse has participated in the fabrication of the sectors of the vacuum vessel, as part of the Fusion for Energy (F4E) Consortium with its partners Ansaldo Nucleare and Walter Tosto. Westinghouse will be responsible for completing the vacuum vessel which is ITER’s most critical component: a hermetically sealed, double-walled steel container that will house the fusion plasma. When all the vacuum vessel sectors are in place, Westinghouse will start the most intensive stage of ITER assembl
Monetate Acquires SiteSpect to Deliver AI-Native Personalization and Testing at Enterprise Scale30.6.2025 16:00:00 EEST | Press release
Monetate, the leading AI-driven personalization platform, today announced it has acquired SiteSpect, a leader in A/B testing, to drive next-generation digital experience optimization. This acquisition accelerates Monetate’s vision to deliver intelligent, intentional, and individualized experiences at scale, powered by agentic AI and backed by the industry’s most advanced, enterprise-grade infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250630514541/en/ The combination of Monetate’s real-time personalization and SiteSpect’s zero-flicker testing will yield an industry-first solution for enterprise-grade personalization, testing, and optimization. For the first time, global ecommerce and digital experience leaders can access unified client-side and server-side experimentation with full personalization capabilities in a single solution, designed for scalability and regulatory compliance. Monetate is now the only e
SS&C Blue Prism Recognized as a Gartner® Magic Quadrant™ RPA Leader for the Seventh Consecutive Year30.6.2025 16:00:00 EEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that SS&C Blue Prism has been recognized as a Leader in the 2025 Gartner Magic Quadrant for Robotic Process Automation (RPA). “We’re delighted SS&C Blue Prism has been named a Leader in the Gartner Magic Quadrant for Robotic Process Automation for the seventh year running,” said Bill Stone, CEO and Chairman of SS&C Technologies. “SS&C Blue Prism combines market-leading RPA and orchestration technologies with the latest artificial intelligence so organizations can tackle more complex tasks and dynamic business processes. We’ve scaled to more than 2,700 digital workers and AI agents across our own operations, resulting in over $200 million in annual savings. With SS&C leading the charge on deployment, customers can be confident in rolling out SS&C’s automation solutions securely, effectively, and responsibly.” More than 2,800 companies worldwide leverage SS&C Blue Prism for AI-powered automation, helping organizations delive
Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 130.6.2025 15:00:00 EEST | Press release
Takeda(TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). As a ready-to-use liquid, GAMMAGARD LIQUID ERC may help ease the administration burden for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously.1 “The approval of GAMMAGARD LIQUID ERC reinforces our commitment to supporting individualized treatment approaches for people with primary immunodeficiency, including a therapeutic option that has the lowest IgA content of any ready-to-use liquid immunoglobulin therapy, and can be administered intravenously or subcutaneously,” said Kristina Allikmets, s
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom