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**Nadofaragene firadenovec + pembrolizumab** is an investigational combination therapy under clinical evaluation for the treatment of non-muscle invasive bladder cancer (NMIBC), specifically in patients with Bacillus Calmette-Guérin (BCG)-unresponsive or high-grade disease[2][3][1]. Nadofaragene firadenovec is a nonreplicating adenoviral vector-based gene therapy that delivers the human interferon alfa-2b gene to bladder epithelial cells, resulting in local production of interferon alfa-2b, which exerts anti-tumor and immunostimulatory effects[1]. Pembrolizumab is a monoclonal antibody targeting the programmed cell death protein 1 (PD-1), functioning as an immune checkpoint inhibitor that blocks the PD-1/PD-L1 pathway, thereby augmenting anti-tumor immune responses. The combination aims to leverage both gene-mediated local immune stimulation (interferon alfa-2b) and systemic immune checkpoint blockade (anti-PD-1) for enhanced anti-cancer activity[2][3]. Clinical trials are ongoing to evaluate the safety and efficacy of this regimen in NMIBC[1][2][3].
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