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Nadofaragene firadenovec effective in BCG-unresponsive papillary NMIBC

A multicentre, open-label, phase 3 study investigating nadofaragene firadenovec for high-grade, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) achieved encouraging, durable, high-grade, recurrence-free (HGRF) survival.

Dr Neal Shore (Carolina Urologic Research Center, USA) presented the outcomes of the papillary disease (PD) cohort from the trial [1]. Nadofaragene firadenovec is a novel intravesical-administered adenovirus-mediated gene therapy (rAd-IFN) delivering the human *interferon (IFN) α2b gene*. When combined with the excipient Syn3, rAd-IFN/Syn3 has been shown in a phase 2 trial to be well tolerated and leads to sustained localised *IFNα2b* gene expression.

The phase 3 trial enrolled 157 patients (mean age 71 years), 50 of whom had PD. Intravesical administration of nadofaragene firadenovec (3×1011 viral particles/mL [75 mL]) was...



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