JANSSEN
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. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210209005492/en/
About Business Wire
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
Stafford Establishes Timberland Continuation Fund at USD 1.2 billion4.12.2025 10:53:00 CET | Press release
This marks Stafford’s second timberland fund at over USD 1 Billion in 2025, backed by strong existing investor support and new capital commitments from global institutional investors Stafford Capital Partners (“Stafford”) today announced it has established a USD 1.2 billion continuation vehicle, the Stafford International Timberland Continuation Fund (The Continuation Fund or The Fund), marking a significant milestone in the firm’s strategic management of its timberland holdings. The Continuation Fund is a "roll-up" of three of Stafford’s existing core timberland funds – Stafford International Timberland funds VI, VII and VIII – into a new perpetual fund that will hold 74 high-quality core timberland assets. The fully-deployed portfolio took Stafford seven years to construct and holds interests in over 6.3m acres of commercial timberland in the USA, New Zealand, Australia and Latin America. This includes a number of assets that are seen as key strategic holdings in these regions where
Smartstream Introduces Agentic AI ‘Smart Agents’ for Investigations and Exceptions Handling4.12.2025 09:55:00 CET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces the preview of Smart Agents for Investigations, a breakthrough in financial operations that brings augmented and autonomous exception handling to reconciliations and back-office processes. The new investigation agent combines domain-trained AI agents, workflow adoption, and embedded controls to triage, investigate, resolve, and learn from exceptions - reducing manual effort, accelerating time to resolution, and strengthening auditability. It will add a layer of intelligence on top of Smartstream’s current reconciliations and exceptions solutions. It understands the breaks context, adheres to customer playbooks and reaches out for missing information. It documents every step for audit and compliance, allowing analysts to focus on risk. Finally, it augments the analyst’s investigation with contextual information radically changing the user experience to review and a
LabGenius Therapeutics Announces New Collaboration with Sanofi for Multiple AI/ML-driven Antibody Optimisation Programmes4.12.2025 09:00:00 CET | Press release
The companies have entered into a new collaboration where LabGenius Therapeutics will apply its ML-driven antibody discovery platform (EVA™) to optimise potential therapeutic NANOBODY® proteins for multiple new targets LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise potential therapeutic antibodies, today announced a second collaboration with Sanofi. This collaboration combines LabGenius’ AI/ML-driven antibody design capabilities with Sanofi’s expertise in the development of therapeutic NANOBODY® molecules to co-optimise proteins for therapeutically valuable properties. Following the success of their first collaboration, LabGenius will apply the EVA™ platform to optimise NANOBODY® molecules for multiple new targets in the area of inflammation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204759388/en/ “We are truly excited abo
GoWit One: The Unified AI Operating System Set to Revolutionize Commerce & Retail Media4.12.2025 07:09:00 CET | Press release
WPP Turkey has been selected as a pilot partner to deploy GoWit One, cutting campaign setup time to 10 minutes. GoWit, a global AdTech leader in omnichannel Commerce and Retail Media, announced the launch of GoWit One, the unified AI operating system that brings automation, unification, and real-time intelligence into a single ad platform for agencies operating across multiple retailers, channels, and markets. By bringing these three elements into one dashboard, GoWit One addresses the industry's most critical bottleneck: operational inefficiency. The platform enables agencies to manage campaigns across multiple retailers, channels, and markets, reducing manual AdOps workflows by 98%, turning a process that used to take hours into as little as 10 minutes. Solving the “Fragmentation Crisis” Despite the explosive growth of Retail Media, the industry faces a significant hurdle. According to the IAB, 70% of the market still lacks end-to-end AI adoption. Media buyers are currently forced to
Galderma Secures ‘BBB’ Credit Rating With Positive Outlook from S&P Global Ratings4.12.2025 07:00:00 CET | Press release
‘BBB’ long-term issuer credit rating from S&P Global RatingsPositive outlook, reflecting expected profitability improvement, ramp up of Nemluvio, and continued deleveraging and balance sheet improvementRecognition of Galderma’s science-based dermatology portfolio and global operations Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that S&P Global Ratings (S&P) has assigned the company a ‘BBB’ long-term issuer credit rating with a positive outlook. The rating reflects Galderma’s strong track record of growth and its leading positions across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. S&P notes the company’s well-established brand portfolio, global footprint, including an expanding presence in emerging markets, and continued investment in science-based innovation. S&P highlights momentum from recent launches, including Nemluvio® (nemolizumab), alongside improving profitability and expanding free operating cash flow
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