The UroOnc Minute: KEYNOTE-B15 and Perioperative Therapy in MIBC, with Dr. Alfonso Gómez de Liaño Lista

Welcome back to The UroOnc Minute!

In this episode of The UroOnc Minute, host Adam B. Weiner, MD, is joined by Dr. Alfonso Gómez de Liaño Lista, a medical oncologist from the Universidad de Las Palmas de Gran Canaria in Spain, for a timely discussion on the phase 3 EV-304/KEYNOTE-B15 trial (NCT04700124), which evaluated perioperative treatment with enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.¹ As perioperative treatment strategies rapidly evolve, Gomez de Liaño Lista explains why the study may help redefine the standard of care for patients with urothelial carcinoma of the bladder.

The trial compared standard neoadjuvant cisplatin-based chemotherapy followed by radical cystectomy vs a perioperative regimen of enfortumab vedotin plus pembrolizumab before surgery and continued afterward. Gomez de Liaño Lista highlights the study’s strong efficacy signals, including significant improvements in event-free survival (HR, 0.53; 95% CI, 0.41 to 0.70; 1-sided P < .0001), overall survival (HR, 0.65; 95% CI, 0.48 to 0.89; 1-sided P = .0029), and pathologic complete response rates (55.8% vs 32.5%; estimated difference, 23.4%; 95% CI, 16.7 to 29.8; 1-sided P < .0001). According to Gomez de Liaño Lista, these findings position the regimen as a major advancement for both cisplatin-eligible and historically underserved patient populations.

Beyond efficacy, the episode offers practical insights for urologists who will increasingly co-manage these patients in multidisciplinary settings. Gomez de Liaño Lista reviews the real-world tolerability of treatment, expected adverse events such as pruritus and diarrhea, and the reassuring surgical completion rates seen in the trial despite concerns about added perioperative toxicity. He also emphasizes the importance of viewing the regimen as a complete therapeutic package rather than isolating neoadjuvant or adjuvant components at this stage of interpretation.

Looking ahead, Weiner and Gomez de Liaño Lista explore the next frontier in bladder cancer care: bladder preservation. With response rates rising dramatically through novel immunotherapy-based combinations, future trials may determine whether select patients can safely avoid cystectomy altogether. The discussion also touches on the potential role of ctDNA, urine biomarkers, imaging, and repeat TURBT in guiding these decisions. For clinicians navigating the changing landscape of bladder cancer management, this episode delivers a concise but high-yield update on where the field stands, and where it may be headed next.

REFERENCE

1. Galsky MD, Pérez-Valderrama B, Maruzzo M, et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. Presented at: 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium. February 26-28, 2026. San Francisco, California. Abstract LBA630. https://www.asco.org/abstracts-presentations/256834/abstract