New data from Phase 2b SunRISe-1 study show rapid complete response (CR) achievement with 98% achieving a CR within 12 weeks.

TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients

Updated results from Cohort 2 of the Phase 2b SunRISe-1 study evaluating the efficacy and safety of investigational TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, who are ineligible for, or decline, radical cystectomy were featured in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place May 3-6, 2024, in San Antonio, Texas.

"The high complete response rate and durability of these responses observed in patients treated with TAR-200 underscores the potential of this treatment approach for patients with BCG-unresponsive HR-NMIBC," said Joseph Jacob,* M.D., M.S., Department of Urology, Upstate Medical University, presenting author. "These results address an area of high unmet need for bladder-sparing therapies in this patient population."

Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy. The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI], 70.6-91.4). The study protocol did not allow retreatment for nonresponders, consistent with U.S. Food and Drug Administration (FDA) guidance. The estimated 1-year duration of response (DOR) rate is 74.6% (95% CI, 49.8-88.4), with median follow-up in responders of 29.9 weeks (range, 14-140); 41 of 48 responders (85%) remain in CR at data cutoff as of January 2, 2024, and none of the responders progressed to muscle-invasive bladder cancer or metastasis. Ninety-eight percent (47 of 48) of CRs were achieved at first disease assessment at week 12, and four of five patients who have completed two years of treatment remain in CR. The investigator-assessed confirmed CR rate correlated strongly with central results.

Interim results from the SunRISe-1 study were featured at the European Society for Medical Oncology 2023 Congress and shared at AUA 2023. These results were also presented at the European Association of Urology 2024 Congress.

Treatment-related adverse events (TRAEs) occurred in 61 patients (71.8%). The most common (≥10%) were pollakiuria (35.3%), dysuria (29.4%), micturition urgency (15.3%), and urinary tract infections (15.3%). Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs. Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.

"These study results mark a significant step in our mission to bring new treatment options to patients that focus on bladder preservation and long-term survival," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. "These results reinforce the potential of TAR-200 to transform the treatment landscape and our ongoing dedication to address unmet needs for patients facing this challenging disease."

TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician's office setting during a 3- to 5-minute procedure with no anaesthesia. In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with  BCG-unresponsive HR-NMIBC, who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder).

Bladder cancer is the sixth most common cancer in the U.S., with more than 83,000 patients diagnosed each year, with NMIBC accounting for about 75-85% of all newly diagnosed bladder cancers. Although BCG immunotherapy has been accepted as the standard of care for nearly five decades, 30-40% of patients do not respond to BCG and experience disease recurrence or progression. In such scenarios, radical cystectomy (removal of the bladder and neighbouring structures and organs) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.

Source: Johnson & Johnson