TAR-200 Intravesical Gemcitabine Device Posts 82% CR in BCG-Unresponsive CIS (Phase IIb)

TAR-200 is an osmotic intravesical drug-releasing system for sustained gemcitabine delivery; in SunRISe-1, BCG-unresponsive high-risk NMIBC received TAR-200 alone, TAR-200+cetrelimab (PD-1), or cetrelimab alone (parallel cohorts). In CIS±papillary disease (C2, n=85), TAR-200 monotherapy achieved 82.4% CR with median DoR 25.8 mo; in papillary-only disease (C4, n=52), 12-mo DFS was 70.2%; grade≥3 TRAEs were 12.9% (C2) and 13.5% (C4), versus higher with the combo (37.7%). Compared with single-arm benchmarks—pembrolizumab 41% 3-mo CR (with 46% of CRs ≥12 mo), nadofaragene 51% 3-mo CR (median DoR 9.7 mo), and N-803+BCG 62% CR (58% of CRs ≥12 mo)—TAR-200’s CR/DoR looks numerically higher while maintaining tolerability.