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New Clinical Trial Results Stir Up Bladder Chatter Among Oncologists at ESMO 2023


Treatment options are limited for patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who are unresponsive to the standard-of-care, intravesical bacillus Calmette-Guérin (BCG). Those who do not response to BCG face radical cystectomy.


Janssen presented its latest SunRISe-1 Phase IIb study results for the TAR-200, an intravesical drug delivery system designed to provide sustained and local release of gemcitabine into the bladder. In this study, patients were randomized into one of three cohorts: i) treatment with TAR-200 combined with cetrelimab (an IV administered programmed cell death receptor-1 (PD-1) monoclonal antibody), ii)TAR-200 monotherapy, or iii) cetrelimab alone. The results revealed that 77% of bladder cancer patients achieved a complete response (CR) with TAR-200 alone.


The safety and efficacy of the TAR-200 system continue to be evaluated in Phase II and Phase III studies in muscle-invasive bladder cancer in SunRISe-2 and -4 and NMIBC in SunRISe-1 and -3.


These exciting TAR-200 system results provide a glimmer of hope for patients with HR-NMIBC with a less invasive and effective treatment option.


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