TUESDAY, July 28, 2026 (HealthDay News) -- For adults with muscle-invasive bladder cancer, the combination of enfortumab vedotin and pembrolizumab is associated with improved event-free and overall survival compared with cisplatin and gemcitabine, according to a study published in the July 23 issue of the New England Journal of Medicine.
Matthew D. Galsky, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a phase 3 open-label, randomized trial involving adults with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy and radical cystectomy with pelvic lymph-node dissection (cystectomy). A total of 405 participants were assigned to receive neoadjuvant and adjuvant enfortumab vedotin-pembrolizumab and 403 were assigned to receive neoadjuvant cisplatin-gemcitabine.
Overall, 86.7 and 89.6 percent of participants in the enfortumab vedotin-pembrolizumab group and the cisplatin-gemcitabine group, respectively, underwent cystectomy. The researchers found that at two years, the estimated event-free survival was 79.4 and 66.2 percent with enfortumab vedotin-pembrolizumab and cisplatin-gemcitabine, respectively (hazard ratio for an event or death, 0.53), while estimated overall survival was 86.9 and 81.3 percent, respectively (hazard ratio for death, 0.65). Of the participants, 55.8 and 32.5 percent, respectively, had a pathological complete response. The corresponding incidence rates of grade 3 or higher adverse events of any cause were 75.7 and 67.2 percent, respectively.
"This study demonstrates that enfortumab vedotin and pembrolizumab can provide better outcomes than standard cisplatin-based chemotherapy, reducing the risk that cancer will return or spread after surgery," Galsky said in a statement. "These findings represent a major step forward and are likely to change the standard of care for patients around the world."
Several authors disclosed ties to biopharmaceutical companies, including Astellas Pharma and Pfizer, which manufacture enfortumab vedotin and partially supported the study.
