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Thomas Flaig, MD


ESMO 2023: Phase II Trial of Novel Drug Delivery System in High-Risk Bladder Cancer

By: Joshua D. Madera, MD
Posted: Monday, November 13, 2023

Use of the intravesical drug delivery system TAR-200 as monotherapy to administer prolonged gemcitabine to patients with bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer may be a suitable treatment option that leads to durable responses and a favorable tolerability profile, according to the results of the phase II SunRIse-1 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract LBA105). Additional investigative efforts are warranted to elucidate the extent of the benefit of this therapeutic strategy, suggested Andrea Necchi, MD, of IRCCS San Raffaele Hospital, Milan, Italy, and colleagues.

A total of 54 patients with bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer were included in the TAR-200 monotherapy cohort within this study. All had histologically confirmed carcinoma in situ. Patients received TAR-200 every 3 weeks for the first 24 weeks, followed by every 12 weeks until the 96th week of treatment. In addition, patients’ clinical status was monitored regularly with cystoscopy, urine cytology, CT, MRI, and bladder biopsies performed at weeks 24 and 48.

A complete response, as determined by urine cytology and/or biopsy, was observed in 77% of patients (n = 23). Of these 23 patients, 21 continued to demonstrate a complete response. Furthermore, treatment-related adverse effects were reported by 54% of patients. They included dysuria, pollakiuria, and micturition urgency. Moreover, grade 3 or greater treatment-related adverse events were experienced by 7% of patients, 4% of whom discontinued treatment because of their severity.

Disclosure: For full disclosures of the study authors, visit

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