J&J’s Novel Drug-Device Combination Demonstrates Success in Intermediate Bladder Cancer Trial

Johnson & Johnson published its Phase IIb SunRISe-1 trial update, revealing the performance of its elyth-200 drug-device combination for inducing remission among patients with high-risk non-muscle invasive bladder cancer (NMIBC). This declaration, made during the 30th annual meeting of the AUA, was based on information from 85 NMIBC patients with carcinoma in situ who either underwent radical cystectomy or opted out of it.
The results, which showed a confirmed complete response rate of 82.8%, were assessed through biopsies or urine cytology.
Almost all complete responses occurred within 12 weeks of treatment initiation, according to Johnson & Johnson’s report. Additionally, the report indicated that nearly 75% of participants maintained a complete treatment response as of January 2nd, with over 85% of those responders maintaining this status until the end. Furthermore, none of the subjects undergoing this approach developed invasive muscle or metastatic disease, suggesting its efficacy.
Christopher Cutie, J&J’s vice president and manager of bladder cancer, stated that this was a crucial step towards J&J’s goal of offering bladder cancer patients an alternative treatment that preserves the bladder and focuses on long-term survival. He positioned TAR-200 as a biomaterial with the capability to change the NMIBC treatment paradigm and drew a resemblance to the disruption it could cause in the current treatment landscape.

TAR-200, specifically designed for prompt installation, is a drug delivery system that ensures gemcitabine is administered directly into the bladder in measured amounts. Through this augmented drug-device combination, the bladder is continuously exposed to the anti-cancer drug for a period spanning the installation process only, which typically lasts 3 to 5 minutes and can conveniently be conducted by a doctor in their office without the need for anesthesia.
The investigational immune checkpoint inhibitor TAR-200 will be evaluated in the SunRISe-1 trial to determine its effectiveness when used alone or in combination with the intravenous PD-1 blocker cetrelimab. The trial, consisting of 200 patients, primarily aims to check the complete response followed by secondary endpoints such as duration of response, overall survival, and quality of life.
J&J is also currently conducting Phase III SunRISe-3 and SunRISe-5 trials to evaluate TAR-200 in NMIBC patients, as well as SunRISe-2 and SunRISe-4 trials to test it in HBLN patients. The launch of a new drug for the treatment of bladder cancer adds value to J&J’s portfolio, which has thrived since the FDA approval of Balversa in January 2024, effective in locally advanced or metastatic urothelial carcinoma, the aggressive form of the disease.

The same group of regulatory members who approved ImmunityBio’s IL-15 superagonist Anktiva along with Bacillus Calmette-Guérin to aid NMIBC noted that novel treatment methods are being developed at a rapid pace to help bladder cancer patients.