According to preliminary results from the SunRISe-1 study, a significant number of patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) prefer bladder-sparing treatments over radical cystectomy. The study, which enrolled patients in the TAR-200 (JNJ-63723283) monotherapy cohort, found that 52% of patients refused radical cystectomy due to a preference for bladder preservation, with 37% citing concerns about quality of life.
TAR-200 is an investigational targeted releasing system designed to deliver sustained local release of gemcitabine into the bladder. The FDA granted TAR-200 a breakthrough therapy designation in December 2023 for treating BCG-unresponsive high-risk NMIBC patients ineligible for radical cystectomy.
Joseph M. Jacob, MD, from the Department of Urology at Upstate Medical University, Syracuse, New York, emphasized the importance of developing effective treatments that align with patients' desires for bladder preservation and improved quality of life. The study's findings support further exploration of TAR-200 as a viable treatment option for this patient group.
The SunRISe-1 study investigates TAR-200, a silicone intravesical device that provides a slow, sustained release of gemcitabine over approximately seven days, offering a novel approach to treating BCG-unresponsive NMIBC patients. This method contrasts with traditional intravesical chemotherapy, where the drug remains in the bladder for only 1 to 2 hours.
Patients enrolled in the study are typically heavily pretreated with BCG and are considered BCG-unresponsive, indicating a high likelihood of disease progression if BCG treatment continues. The availability of TAR-200 monotherapy as an alternative to cystectomy has significantly impacted patient willingness to participate in the study, with many motivated by the prospect of preserving their bladder.
Key takeaways from the study include the strong patient preference for bladder preservation and the promising preliminary results of TAR-200 monotherapy, with nearly 80% of patients achieving a complete response. The next steps involve gathering more data to assess the durability of the treatment response and its effectiveness as a long-term solution for BCG-unresponsive high-risk NMIBC patients.
