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For patients and clinicians, bacille Calmette-Guérin (BCG)–unresponsive bladder cancer remains a major therapeutic dilemma. While the checkpoint-inhibitor pembrolizumab is approved in this clinical setting, most patients are faced with the need to proceed to radical cystectomy if they are candidates.
Nadofaragene firadenovec is “a non-replicating recombinant adenovirus vector-based gene therapy that delivers a copy of the human interferon alfa-2b gene to urothelial cells” in combination with Syn3, a polyamide surfactant that enhances viral transduction.
Investigators conducted a multicenter single-arm, open-label study in 151 patients with an FDA definition of BCG-unresponsive non–muscle-invasive bladder cancer, which includes “patients with …