Business Wire

Janssen Announces Treatment with ERLEADA®▼(apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Share

FOR EMEA PHARMACEUTICAL TRADE AND MEDICAL MEDIA ONLY - NOT FOR DISTRIBUTION IN BENELUX, SWEDEN AND ITALY

Janssen Pharmaceutica NV (Janssen) announced today results from the final analysis of the Phase 3 TITAN study, which demonstrated the continued statistically significant benefit of apalutamide plus androgen deprivation therapy (ADT) in overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) when compared to placebo plus ADT.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 #11; Rapid Abstract Session: Prostate Cancer, February 11 9:30 PM-10:15 PM CET).

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that apalutamide plus ADT provided statistically significant improvement in OS with a 35 percent reduction in risk of death compared to ADT alone (HR 0.65; p<0.0001).1 This result was almost similar to the OS results in the primary analysis of TITAN despite the subsequent crossover rate of almost 40 percent of the placebo-controlled group to the apalutamide arm.1 The improvement in OS increased to a 48 percent reduction in risk of death after adjusting for patients who crossed over (HR 0.52; p<0.0001).1

“Janssen is committed to uncovering new solutions for patients with prostate cancer as until very recently, there has been little advancement in treatment options for people with metastatic hormone-sensitive prostate cancer,”2 said Dr Catherine Taylor, Vice-president, Medical Affairs, Therapeutic Area Strategy for Europe, Middle East and Africa, Johnson & Johnson Middle East FZ-LLC. “The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer.”

There was consistent benefit across other endpoints, including improved second progression-free survival (PFS2) (HR 0.62; p<0.0001) and delayed time to castration resistance (HR 0.34; p<0.0001).1 In addition, health-related quality of life (HRQoL), per total Functional Assessment of Cancer Therapy–Prostate (FACT-P), continued to be maintained in both groups. Safety of apalutamide was consistent with previously reported studies.1 Observed adverse events included skin rash, fracture, and falls.1

“The TITAN final analysis is a welcome development for the management of metastatic hormone-sensitive-prostate cancer2 as the data show us that apalutamide with ADT improves long-term clinical benefit and prolonged overall survival, without compromising health-related quality of life for these patients,” said Professor Axel Merseburger, Chairman of the Clinic of Urology, Universitatsklinikum Schleswig-Holstein and investigator of the TITAN study. “The results also demonstrate an established safety profile which is encouraging for the management of patients living with advanced forms of prostate cancer.”

Initial results from the TITAN study presented at the 2019 American Society of Clinical Oncology Annual Meeting (ASCO) and simultaneously published in The New England Journal of Medicine showed the addition of apalutamide to ADT compared to placebo plus ADT significantly improved the dual primary endpoints of OS and radiographic progression-free survival (rPFS) in patients with mHSPC.3

To date, published results on apalutamide include data from more than 2,000 patients across Phase 3 clinical studies.3 Apalutamide has shown a statistically significant improvement in OS with a consistent safety profile in both approved indications of mHSPC (TITAN) and non-metastatic castration-resistant prostate cancer or nmCRPC (SPARTAN).3

*Professor Axel Merseburger is an investigator of the TITAN study and has been compensated for media work.

About the TITAN Study 3,4

TITAN (NCT02489318) is a Phase 3, randomised, placebo-controlled, double-blind study in patients with mHSPC. The study included 1,052 patients in 23 countries across 260 sites in North America, Latin America, South America, Europe, and Asia Pacific. Patients with mHSPC were randomised 1:1 and received either apalutamide (240 mg) plus ADT (n=525), or placebo plus ADT (n=527). The recruitment period for the study spanned from December 2015 to July 2017.3,4 The study included patients with mHSPC with both low- and high-volume disease, those who were newly diagnosed, and those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel for mHSPC.3,4

An Independent Data-Monitoring Committee was commissioned by the sponsor to monitor safety and efficacy.5 Dual primary endpoints of the study were OS and rPFS.1 Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use, and time to skeletal-related events.3,4 Exploratory endpoints included time to prostate specific antigen (PSA) progression, PFS2 and time to symptomatic progression.3,4 For additional study information, visit ClinicalTrials.gov.

About Metastatic Hormone-Sensitive Prostate Cancer

Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body.5

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).6

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 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 Pharmaceutica NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 Pharmaceutica NV, and/or 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 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 29, 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. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Date of preparation: February 2021

Job code: CP-209580

References

1 Chi, K. Final Analysis Results From TITAN: A Phase 3 Study of Apalutamide (APA) vs Placebo (PBO) in Patients (pts) With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) Receiving Androgen Deprivation Therapy (ADT). ASCO GU 2021 oral presentation.

2 Hall, M, E. et al. Metastatic Hormone-sensitive Prostate Cancer: Current Perspective on the Evolving Therapeutic Landscape. NCBI. 2020; 13: 3571–3581. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201221/. Last accessed February 2021.

3 ERLEADA Prescribing Information, September 17, 2019.

4 ClinicalTrials.gov. A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (TITAN). Available at: https://clinicaltrials.gov/ct2/show/NCT02489318. Last accessed February 2021.

5 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2018). http://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf. Last accessed February 2021.

6 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.

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

Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus8.3.2021 09:00:00 EETPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/ Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application. The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is supported by positive data from two pivotal phase-III trials KALM-1, condu

HD-PLC Alliance Develops Its Global Activities in High-speed Power Line Communications and High-speed Wired Communications8.3.2021 09:00:00 EETPress release

Last year, HD-PLC Alliance *1, Fukuoka, Japan (Alliance) launched the “Global Strategy Preparatory Office”, a new ad-hoc working group, to support the advancement of IoT migration which is leading to a dramatic growth of the needs for high-speed PLC in various systems such as smart-meter, factory-automation (FA), building-automation (BA), solar power generation, smart-streetlight, smarter-city, smarter-home, etc. The Alliance announces today several initiatives as part of the development of its global activities. First, the Alliance will hold an HD-PLC *2 global web seminar (webinar) jointly with IEEE SA*3 on coming Thursday, 18th March to showcase its ecosystem footprint. Event title: [IEEE SA And HD-PLC Alliance Webinar March 2021] Home Networking, Industrial and Building Automation through HD-PLC (High Speed Powerline Communication) Official website: https://hd-plc.org/news/ , https://standards.ieee.org/events/index.html Topics covered/Agenda: HD-PLC technology and Standards, Buildi

Masimo Monitoring Solutions Promote Newborn and Maternal Safety8.3.2021 08:00:00 EETPress release

Masimo (NASDAQ: MASI) provides a variety of innovative monitoring solutions designed to improve maternal and newborn safety during childbirth and the critical first minutes of life. Masimo SET® pulse oximetry’s ability to measure during motion and low perfusion has helped newborns, neonates, and pediatric patients like no other pulse oximetry. Not only has Masimo SET® helped clinicians reduce retinopathy of prematurity (ROP)1 and improve screening for critical congenital heart disease (CCHD),2-10 but it has helped push the standard of care for babies to new heights—the evidence from CCHD studies with SET®, for example, has been used in the establishment of screening guidelines used around the world.11 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005058/en/ Masimo Newborn Sensor (Photo: Masimo) Today, on International Women’s Day, it is especially important to recognize that, as UNICEF reports, “newborns and mothers a

High-Quality Healthcare, Education Systems Highlighted in China's Two Sessions7.3.2021 06:41:00 EETPress release

Building Healthy China and a high-quality education system are both important content in the draft outline of the 14th Five-Year Plan (2021-2025) for national economic and social development and the long-range objectives through the year 2035, which will be reviewed by lawmakers at the ongoing National People's Congress (NPC) session. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210306005020/en/ On the second day of this year's annual session of the NPC, China's national legislature, President Xi Jinping joined a group meeting with national political advisors from the education, medical and health sectors. He attended joint group meetings with national political advisors from various sectors during the Two Sessions eight times from 2013 to 2020, hearing their comments and suggestions. Ensuring people's health Talking about work in medical and health areas, Xi reiterated holding people's health as a strategic priority, call

CGTN: China Outlines Plan to Address Economic Challenges in Next 5 Years5.3.2021 16:02:00 EETPress release

China has set a gross domestic product (GDP) growth target of over six percent for 2021 and outlined a plan to promote innovation, green development, and common prosperity in the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005288/en/ Addressing the country's annual legislative session, Premier Li Keqiang on Friday explained how China is going to tackle the numerous challenges it faces in a new development stage. "China remains in an important period of strategic opportunity for development. Yet, there are changes in both the opportunities and challenges we face," Li said when delivering a government work report at the opening meeting of the fourth session of the 13th National People's Congress (NPC), China's top legislature. 'Extraordinary year' Describing 2020 as "an extraordinary year in the history of the People's Republic of China," the premier underscored China's "major strategic success" in fi

Everbridge Awarded Revolutionary New Public Warning Patent for Technology that Automates the Selection of the Optimal Communications Channels to Reach the Broadest, Hyper-Targeted Populations – as Fast as Possible – During a Crisis5.3.2021 15:30:00 EETPress release

Everbridge, Inc. (NASDAQ: EVBG), the global leader in critical event management (CEM), today announced the company received a revolutionary new patent related to its world-class Public Warning system. The patent pertains to technology focused on hybrid population alerting systems and intelligent sending of messages in public mobile networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210305005260/en/ Everbridge Awarded Revolutionary New Public Warning Patent (Photo: Business Wire) Everbridge represents the first population alerting provider to serve the entire populations of 11 countries in Europe, Asia, Oceania, the Middle East, Africa, and the Americas, supporting five European Union (EU) countries in conjunction with the EU mandate requiring member countries to have a population-wide alerting system in place by June 2022. In compliance with GDPR, Everbridge Public Warning neither collects nor stores personally identif

COVID-19’s Economic Pinch Drives More Nordic Enterprises Toward Business Process Automation for Competitive Edge5.3.2021 12:00:00 EETPress release

Large enterprises in the Nordics have been implementing business process automation over the last three years, and more organizations now see the urgency of adopting these technologies to stay competitive as COVID-19 strains the regional economy, according to a new report published today by Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm. The 2020 ISG Provider Lens™ Intelligent Automation – Solutions and Services report for the Nordics finds banking, financial services and insurance companies have led the region in adopting business process automation, seeking higher productivity, cost savings and improved customer experience. Manufacturing, retail and other sectors are also embracing the technologies, which include conversational AI, natural-language processing and AI for IT operations (AIOps). “Early adopters of automation in the Nordics are stepping up digital transformation to gain an advantage when they need it most,” said Jan

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