Real-World GUARDIANS Study Evaluates Enfortumab Vedotin-Pembrolizumab in

A multi-institutional real-world analysis called GUARDIANS assessed how enfortumab vedotin plus pembrolizumab performs outside clinical trial settings in urothelial cancer. Published in Cancer Immunology, Immunotherapy, the study evaluates both effectiveness and safety across routine oncology practice, aiming to reflect the broader, more medically complex patient population commonly seen in everyday care. The article outlines the regimen’s dual mechanism: enfortumab vedotin targets Nectin-4 and delivers the cytotoxic payload monomethyl auristatin E (MMAE) to disrupt microtubules, while pembrolizumab blocks PD-1 to counter tumor-driven immune suppression. It also highlights why real-world evidence matters given trial eligibility limits around organ function, performance status and comorbidities.