Johnson & Johnson is officially set to showcase new data from its leading oncology pipeline at the American Urological Association 2025 Annual Meeting.
According to certain reports, the stated lowdown is likely to be headlined by 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study. This particular study assessed TAR-200, an intravesical gemcitabine releasing system, among patients with Bacillus Calmette-Guérin (BCG), unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), and the ones who are suffering from carcinoma in situ (CIS) with or without papillary disease.
To understand the significance of such a development, we must acknowledge how bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year. Out of the given lot, HR-NMIBC makes up nearly 15-44 percent of patients and is characterized by a high-grade, large tumor size, presence of multiple tumors, with or without CIS.
Now, there have been advancements in the given space, but having said so, standard treatment has remained largely unchanged for over 40 years. As a result, patients are often left with limited treatment options if initial BCG therapy does not work.
In response, TAR-200 arrives on the scene bearing an ability to deliver sustained medication directly into the bladder.
“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.”
More on that would reveal how, back in January 2025, Johnson & Johnson filed a new drug application with the FDA for TAR-200 under real-time oncology review (RTOR) program. This came after the FDA had granted Breakthrough Therapy Designation (BTD) to TAR-200, in December 2023, 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.
Markedly enough, a second plenary presentation will also be there to deliver first results from Cohort 4 of the Phase 2b SunRISe-1 study focused on 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. This means they are either struggling against multiple diseases or are unwilling to undergo radical surgery.
Taking a deeper view of the data set to be presented during Phase 2b SunRISe-1 study, it would include TAR-200 monotherapy in patients with BCG–unresponsive, HR-NMIBC plus carcinoma in situ with or without papillary disease.
Next up, the published lowdown is likely to cover 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.
Another component set to join Johnson & Johnson’s presentation would be trial-in-progress mini-oral presentation from the Phase 3 MoonRISe-1 study, which is studying TAR-210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC.
Not just that, it will also pack together data from trial-in-progress related to the Phase 3 SunRISe-5 study, evaluating TAR-200 compared to intravesical chemotherapy after treatment with BCG in patients with recurrent HR-NMIBC.
Rounding up highlights would be the presence of real-world time-to-next-treatment and time-to-castration-resistance among patients with metastatic castration-sensitive prostate cancer. The stated treatment is being done through androgen-receptor pathway inhibitors with and without homologous recombination repair alterations.
“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, 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.”
