Johnson & Johnson (J&J) has reported more data supporting the efficacy of its intravesical drug release system TAR-200 in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
Data, announced during the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology plenary session at the American Urological Association (AUA) Annual Meeting 2025, showed a high response rate in one of the cohorts from the Phase IIb SunRISe-1 trial (NCT04640623). J&J announced new data from both cohort two and cohort four at the conference.
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TAR-200, trademarked as GemRIS, is a drug-device combination product that continuously delivers gemcitabine chemotherapy directly to the bladder over a week. It can be inserted without the need for anaesthesia or sedation. J&J acquired TAR-200 and the drug delivery technology during its purchase of Taris Biomedical in 2019.
In the new data from cohort two, which enrolled 85 BCG-unresponsive NMIBC patients with carcinoma in situ, 82.4% achieved a complete response (CR), with this translating into sustained disease control, with 52.9% of responders maintaining CR at one year. In the same cohort, the median duration of response (DOR) was 25.8 months and at 12 months, 86.6% of patients who responded to treatment remained cystectomy-free.
Meanwhile, patients in cohort four, 52 HR-NMIBC patients with papillary disease-only, 85.3% and 81.1% disease-free survival (DFS) rates at six and nine months. Also, 94.2% of patients avoided cystectomy at a median follow-up of 12.8 months. J&J also reported progression-free (PFS) and overall survival (OS) rates of 95.6% and 98% at nine months, respectively.
In both cohorts, TAR-200, the treatment was well-tolerated, with most adverse events (AEs) being mild urinary symptoms. These findings indicate that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC. Most treatment-related AEs were mild and manageable. Between both cohorts, seven patients discontinued treatment due to treatment-related AEs, and there were no treatment-related deaths.
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By GlobalDataDisease area leader of bladder cancer for J&J Innovative Medicine, Dr. Christopher Cutie, said: “Bladder cancer is one of the ten most common cancers worldwide, yet treatment options have remained largely unchanged for over 40 years, leaving patients with few choices if initial BCG therapy does not work. TAR-200 is designed to allow for sustained delivery of medication directly into the bladder through a brief and routine procedure, which benefits patients. These data now show patients can remain cancer-free for a meaningful period of time, marking a significant step forward for those facing this challenging disease.”
The new data, announced on Saturday 26 April comes after J&J filed a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for TAR-200 in January 2025 based on previous data announced from the SunRISe-1 trial.
The application is for the use of TAR-200 in NMIBC patients with carcinoma in situ who are BCG-unresponsive, with or without papillary tumours. This submission is being reviewed through the Real-Time Oncology Review (RTOR) programme, which allows the FDA to review data before the complete application is formally submitted.
Earlier results from cohort two were presented at the European Society of Medical Oncology (ESMO) Congress 2024 and the AUA 2024 Meeting.
TAR-200 did not, however, show benefit in a Phase III trial in patients with muscle-invasive bladder cancer (MIBC) not undergoing radical cystectomy. The Phase III SunRISe-2 study (NCT04658862) was terminated by J&J after an independent data monitoring committee said the trial was unlikely to meet its primary endpoint of bladder intact-event free survival (BI-EFS). The Phase II SunRISe-4 trial, also in patients with MIBC, is ongoing.
The SunRISe-1 trial is ongoing, and TAR-200 is also being investigated in NMIBC in two Phase III studies, SunRISe-3 (NCT05714202) and SunRISe-5 (NCT06211764).
Also at the AUA Annual Meeting 2025, Pfizer presented positive data from a Phase III trial of sasanlimab and BCG, with the combination therapy improving event-free survival (EFS) in BCG-naïve high-risk NMIBC patients compared to subjects who were only given BCG, meeting the trial’s primary endpoint.
