Overview
Enfortumab vedotin plus pembrolizumab (EV+P) is now the preferred first-line treatment for locally advanced/metastatic bladder cancer (la/m UC), offering improved survival compared to platinum-based chemotherapy. However, EV isn't suitable for all patients—those with certain medical conditions or frailty may be at higher risk for serious side effects. A new real-world study examined treatment patterns and outcomes among patients who would likely be considered unsuitable for EV+P and who are typically excluded from clinical trials.
Researchers analyzed data from 3,500 patients with la/mUC diagnosed between 2020 and 2024 from the Flatiron Health Research Database. Researchers found that 28% had medical conditions making them unsuitable for EV—most commonly due to existing nerve damage, poor kidney function, diabetes, or low performance status. Importantly, nearly one-quarter of these vulnerable patients remained untreated. Those who did receive treatment had significantly shorter survival than healthier patients, regardless of which therapy they received. Median overall survival was only 9.3 months in those deemed unsuitable compared to 17.0 months in patients who were suitable. Notably, different treatment approaches (enfortumab vedotin plus pembrolizumab, chemotherapy, or immunotherapy alone) produced similar outcomes in the vulnerable population.
Why this matters
These findings highlight a critical gap in care for patients with la/mUC who have medical vulnerabilities. As standard treatments offer similar outcomes in this group, individualized treatment decisions that prioritize patient preferences, quality of life, and tolerance—rather than a one-size-fits-all approach—is increasingly important for improving outcomes in this underserved population.