TAR-200 monotherapy was well tolerated, with high complete response rate and prolonged disease-free survival
By Elana Gotkine HealthDay Reporter
THURSDAY, Aug. 21, 2025 (HealthDay News) — For patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC), an intravesical gemcitabine-releasing system, TAR-200 monotherapy, is well tolerated with a high complete response (CR) rate, according to a study published online July 30 in the Journal of Clinical Oncology.
Siamak Daneshmand, M.D., from the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, and colleagues conducted a phase 2b parallel cohort study involving patients with BCG-unresponsive carcinoma in situ with/without papillary disease who received TAR-200 monotherapy, TAR-200 plus cetrelimab, or cetrelimab monotherapy (cohorts [C] 2, 1, and 3, respectively). In addition, patients with BCG-unresponsive high-risk papillary disease-only NMIBC received TAR-200 monotherapy (C4).
Overall, 53, 85, 28, and 52 patients were treated in C1 to C4, respectively, as of data cutoff. The researchers found that the CR rate and median duration of response were 82.4 percent and 25.8 months, respectively, in C2. The six-, nine-, and 12-month disease-free survival rates were 85.3, 81.1, and 70.2 percent, respectively, in C4. CR rates were 67.9 and 46.4 percent in C1 and C3, respectively. In C2, C4, C1, and C3, rates of grade ≥3 treatment-related adverse events were 12.9, 13.5, 37.7, and 7.1 percent, respectively, and rates of serious treatment-related adverse events were 5.9, 5.8, 15.1, and 3.6 percent, respectively. There were no treatment-related deaths.
“The theory behind this study was that the longer the medicine sits inside the bladder, the more deeply it would penetrate the bladder and the more cancer it would destroy,” Daneshmand said in a statement. “It appears that having the chemotherapy released slowly over weeks rather than in just a few hours is a much more effective approach.”
Several authors disclosed ties to pharmaceutical companies, including Johnson & Johnson; the study was funded by Janssen Research & Development, a Johnson & Johnson company.
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