Latest news with #SunRISe-1
Business Insider
28-04-2025
- Business
- Business Insider
Johnson & Johnson announces new data from Cohort 2 of Phase 2b SunRISe-1
Johnson & Johnson announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200-an intravesical gemcitabine releasing system-for patients with certain types of bladder cancer. The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months. These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guerin-unresponsive, high-risk non-muscle-invasive bladder cancer, HR-NMIBC, with carcinoma in situ, CIS, with or without papillary tumors who are ineligible or refuse radical cystectomy. As of March 2025, 82.4 percent of the 85 enrolled patients in the study achieved a complete response, meaning their cancer was undetectable following treatment. This high response rate translated into sustained disease control, with 52.9 percent of responders maintaining complete response at one year. The median duration of response was 25.8 months, indicating that many patients remained cancer-free for over two years without the need for reinduction therapy. At 12 months, 86.6 percent of responders remained cystectomy-free. Importantly, the treatment was well-tolerated, with most adverse events being mild urinary symptoms. These findings show that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC. Stay Ahead of the Market:
Malaysian Reserve
25-04-2025
- Health
- Malaysian Reserve
Weekly Recap: 13 Health Stories You Need to See
A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including new oncology research from Johnson & Johnson and news on Infant Immunization Week. NEW YORK, April 25, 2025 /PRNewswire/ — With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AU TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2). Infant Immunization Week: Protecting Our Youngest Against Measles and MoreAs National Infant Immunization Week arrives, Fidelis Care, along with other health experts and The Centers for Disease Control and Prevention (CDC), urge parents to ensure their children receive timely vaccinations, including the measles-mumps-rubella (MMR) vaccine, to safeguard their health and prevent the spread of infectious diseases. Ginkgo Automation Partners with Aura Genetics to Accelerate Direct-to-Consumer Testing and InnovationThe Reconfigurable Automation Cart (RAC) system, combined with Ginkgo Automation's orchestration software and real-time error resolution services, aims to enable Aura Genetics to efficiently scale and streamline diagnostic testing workflows. Leidos invests $10 million in AI disease detection with University of PittsburghThe initial focus of the five-year collaboration will be developing AI-powered tools for quicker detection of diseases, such as heart disease and cancer, reducing diagnostic turnaround times, and enabling earlier, more effective care management. United To End Blood Cancer: Dedicated Volunteers Across the U.S. are Helping Patients Live Longer Better LivesParticipants have 10 weeks to raise funds that will directly support The Leukemia & Lymphoma Society's (LLS) life-changing work. 'Together, we are helping cancer patients live longer, better lives,' said Coker Powell, LLS Chief Revenue Officer. 99% of lab professionals impacted by medical couriers, survey findsOf the 318 lab professionals who responded to the 2025 CAP Today survey, 84% said that in the last month a medical courier delay or error impacted their ability to provide appropriate and timely results for patients, with an average of three such incidents reported per month per respondent. Next Mission to Space Station Features Nanomaterials to Treat Osteoarthritis, New Materials for Lifelike Robotics, a Holographic Microscope, and MoreA project to manufacture nanomaterials that could provide new treatments for osteoarthritis and cancer joins a trio of investigations funded by the U.S. National Science Foundation (NSF) and more on SpaceX's 32nd Commercial Resupply Services (CRS) mission for NASA to the International Space Station (ISS). WebMD Ignite Launches Enhancements to Coach to Improve Health Plan Member Engagement and Reduce Costs'Today's members expect seamless, mobile-first experiences, and health plans need tools that meet those expectations while driving real outcomes,' said Veronica Short, vice president of Product Management, Healthcare Solutions Group at WebMD Ignite. 'With Coach's enhanced SMS capabilities, care managers can connect with members in the moments that matter—quickly, effectively and at scale.' New York Cancer & Blood Specialists Adopt the DeepScribe Ambient Operating System for Oncology'Bringing our doctors automated documentation and intelligent insights means they can devote more quality time to our patients, and give them the personalized attention and care they deserve,' said Dr. Jeff Vacirca, Oncologist and CEO of NYCBS. BD Launches Industry-First Bioabsorbable Mesh Designed for Umbilical Hernia Repair'BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh,' said Ron Silverman, chief medical officer for BD. Bacteria in Our Aging Guts Can Elevate Risk of LeukemiaNew findings in Nature reveal how age-related gut changes fuel the growth of pre-leukemic blood cells and may increase other disease risks New Report Highlights Surge in Tech Adoption Amid Compliance and Procurement PressuresThe report surveyed 258 hospital pharmacy participants in the first quarter of 2025 to gauge opinions on current challenges, priorities, and trends shaping hospital pharmacies nationwide. Labcorp Launches Molecular Residual Disease and Liquid Biopsy SolutionsStage III colon cancer has a nearly 30% recurrence rate within five years. Labcorp's test detects cancer recurrence risk that conventional methods might miss, helping to identify patients who could benefit from additional treatment or therapy. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at
Associated Press
21-04-2025
- Health
- Associated Press
Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2) Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer RARITAN, N.J., April 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas. Among the highlights are the 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study, evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with Bacillus Calmette-Guérin (BCG)—unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) with or without papillary disease. These findings will be featured in the Practice-changing, Paradigm-shifting Clinical Trials in Urology plenary session on Saturday, April 26. Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year.1 Despite advancements, standard treatment has remained largely unchanged for over 40 years, leaving patients with limited treatment options if initial BCG therapy does not work.2 TAR-200 delivers sustained medication directly into the bladder and, in a pre-clinical setting, has been shown to allow for depth of penetration across bladder tissue layers.3 'Patients with bladder cancer need more effective treatment options that are both tolerable and easily incorporated into everyday practice, especially for those with HR-NMIBC, a highly recurrent disease that often necessitates difficult, life-altering decisions like bladder removal,' said Yusri Elsayed, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. 'TAR-200 provides a new approach, with clinical data showing an impressive complete response rate, meaning the cancer was undetectable following treatment. The highly anticipated 12-month duration of response findings from our Cohort 2, SunRISe-1 study further support the potential for patients to remain cancer-free for a clinically meaningful period.' A second plenary presentation will feature first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, papillary-only HR-NMIBC. In this patient population, bladder removal remains a standard treatment, but many patients are elderly, have significant comorbidities, or are unwilling to undergo radical surgery, making treatment challenging.4 'Patients deserve more than the currently available treatment options. TAR-200 is a groundbreaking therapy for early-stage bladder cancer, designed to deliver a sustained local release of medication directly into the bladder—right where it is needed,' said Biljana Naumovic, U.S. President, Oncology, Solid Tumor, Johnson & Johnson Innovative Medicine. 'This innovation provides a bladder-sparing treatment option that can meaningfully improve outcomes while integrating seamlessly into any urology practice.' TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient, in-office procedure, without the need for anesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of medication throughout the day. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical program. AUA 2025 Presentation Highlights: A complete list of Johnson & Johnson's sponsored abstracts is available on About TAR-200 TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the real-time oncology review (RTOR) program. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG—unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with MIBC in SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5. About TAR-210 TAR-210 is an investigational intravesical erdafitinib releasing system. The safety and efficacy of TAR-210 is being evaluated in a Phase 1 study ( NCT05316155 ) in patients with muscle-invasive bladder cancer (MIBC) and NMIBC. About High-Risk Non-Muscle-Invasive Bladder Cancer High-risk non-muscle-invasive bladder cancer is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.5,6 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, with or without CIS.7 Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.8,9 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.10 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.3,6 About Prostate Cancer Approximately 300,000 people are diagnosed with prostate cancer each year in the U.S.11 Up to 40 percent of patients will be classified as high-risk.12 Despite advancements in treatment, disease recurrence remains substantial; up to 50 percent of patients within ten years of surgery experience recurrence and carry a significant risk of disease progression and death.13 About Johnson & Johnson 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 or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements 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 TAR-200, TAR-210 or BALVERSA® (erdafitinib). 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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC 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 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 or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments. 1 2 Dobruch J, Oszczudłowski M. Bladder Cancer: Current Challenges and Future Directions. Medicina (Kaunas). 2021;57(8):749. Published 2021 Jul 24. doi:10.3390/medicina57080749 3 Pradère B., et al. PENELOPE: Tissue penetration of gemcitabine phosphate metabolites following TAR-200 administration versus standard intravesical instillation in minipigs. EAU 2025. March 23, 2025. 4 Lebacle C, Loriot Y, Irani J. BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know?. World J Urol. 2021;39(11):4037-4046. doi:10.1007/s00345-021-03666-w 5 Grab-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non–muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124. 6 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF. The management of non–muscle-invasive bladder cancer: a comparison of European and UK guidelines. J Clin Urol. 2018;11(2):144-148. 7 Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/ 8 Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475 9 Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949. 10 Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis. Cancer. 2013;119(17):3219-3227. 11 Key statistics for prostate cancer. American Cancer Society. Accessed September 2024. 12 Cooperberg MR, Cowan J, Broering JM, et al. High-risk prostate cancer in the United States, 1990-2007. World J Urol. 2008;26(3):211-218. doi: 10.1007/s00345-008-0250-7. 13 Napodano G, Ferro M, Sanseverino R. High-risk prostate cancer: A very challenging disease in the field of uro-oncology. Diagnostics (Basel). 2021;11(3):400. doi: 10.3390/diagnostics11030400. View original content to download multimedia: SOURCE Johnson & Johnson
