Janssen: 1st Results from Phase 2 Study in Bladder Cancer

 Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy (a novel investigational intravesical drug delivery system) and cetrelimab monotherapy (an investigational anti-PD-1 monoclonal antibody administered intravenously) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy. The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). These data were featured today in a Late Breaker Podium Presentation Session (Abstract #LBA02-03) at the American Urological Association Annual Meeting (AUA).

https://www.biospace.com/article/releases/janssen-reports-first-results-from-phase-2-sunrise-1-study-of-tar-200-and-anti-pd-1-antibody-cetrelimab-in-patients-with-bacillus-calmette-guerin-unresponsive-non-muscle-invasive-bladder-cancer/