Pharmaceutical company Johnson & Johnson (J&J) (NYSE:JNJ) on Saturday 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 company said that 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-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumours, who are ineligible or refuse radical cystectomy (RC). These results were featured at the 2025 American Urological Association (AUA) Annual Meeting.
"Treatment with TAR-200 has long-lasting effectiveness. More than 82% of patients achieved a complete response, and of those that initially responded to treatment, more than half showed no signs of cancer at one year," said Joseph Jacob, M.D., MCR, associate professor of Urology at Upstate Medical University and presenting author. "These findings represent the highest complete response rate observed for patients with HR-NMIBC and underscore the potential of TAR-200 to provide long-lasting cancer control for patients."
TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day, J&J said. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical programme.
AstraZeneca and Daiichi Sankyo's Enhertu shows strong results in early-stage breast cancer trial
Adcentrx's ADRX-0706 granted US FDA Fast Track designation to treat advanced cervical cancer
AstraZeneca secures EU approval for Calquence combo as first-line treatment in mantle cell lymphoma
Phanes Therapeutics doses first patient in peluntamig-atezolizumab combination clinical study
Otsuka's leukaemia drug ponatinib launched on Fangzhou platform
TransCode Therapeutics announces reverse stock split
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
TransCode Therapeutics reports progress in metastatic cancer trial
Ingenium Therapeutics' Gengleucel to enter Phase 2 trial in MRD+ AML following FDA feedback
AllyGPO and BioCareSD advance community oncology through integrated, tech-driven drug management
Nuformix receives positive EMA opinion for orphan drug designation of NXP002 in IPF
Atossa Therapeutics secures new US patent for proprietary (Z)-endoxifen formulations
Myosin Therapeutics receives grant to advance MT-110 clinical trial in methamphetamine use disorder