TAR-200 (intravesical gemcitabine device) vs nadofaragene firadenovec: no statistically significant CR durability difference detected through 24 months in BCG-unresponsive CIS

This reconstructed individual patient data (rIPD) cross-trial analysis digitized published Kaplan–Meier duration-of-response (DoR) curves among complete responders (CR-only) from SunRISe-1 Cohort 2 (TAR-200 monotherapy; an intravesical gemcitabine-releasing system) and the Phase 3 CIS cohort of NCT02773849 (nadofaragene firadenovec; adenoviral vector delivering interferon alfa-2b) in BCG-unresponsive NMIBC with CIS. Restricted mean survival time (RMST) differences in DoR (TAR-200 minus nadofaragene) were small and not statistically significant at 6, 12, 18, and 24 months (−0.29, −0.04, +0.60, and +1.34 months, respectively; all CIs crossed 0). An exploratory Weibull mixture cure model suggested a higher estimated “durable CR fraction” with TAR-200 vs nadofaragene (0.521 vs 0.256; Δ +0.265), but this is inherently fragile given cross-trial differences and conditioning on responders. Both treatments are now FDA-approved bladder-sparing options: TAR-200 was approved as Inlexzo in September 2025 for adults with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, while nadofaragene was previously approved for the same disease setting. For clinical context, nadofaragene’s Phase 3 KM-estimated probability of maintaining CR ≥12 and ≥24 months was ~46.5% and ~36.6% (among responders), while pembrolizumab’s CR durability in KEYNOTE-057 had ~46% of responders maintaining CR ≥12 months (with a much lower overall CR rate ~41%).