TAR-200 shows promise in bladder cancer

Among the highlights are the 12-month duration of response (DOR) data from the Phase IIb 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. 

Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year. 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. 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.

“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., M.H.Sc., 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 presentation will feature first results from Cohort 4 of the Phase IIb 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.

“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: 

i) One-year duration of response data from the Phase IIb SunRISe-1 study evaluating TAR 200 monotherapy in patients with BCG–unresponsive, HR-NMIBC plus carcinoma in situ with or without papillary disease. 

ii) First results from Cohort 4 of the Phase IISunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive papillary-only HR-NMIBC. 

iii) Trial-in-progress mini-oral presentation from the Phase III MoonRISe-1 study evaluating TAR 210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC. 

iv) Trial-in-progress presentation from the Phase III SunRISe-5 study evaluating TAR 200 compared to intravesical chemotherapy after treatment with BCG in patients with recurrent HR-NMIBC. 

v) Real-world time-to-next-treatment and time-to-castration-resistance among patients with metastatic castration-sensitive prostate cancer using androgen-receptor pathway inhibitors with and without homologous recombination repair alterations.