GU Cancers 2026 | KEYNOTE-B15: perioperative EV and pembrolizumab in cisplatin-eligible MIBC
Tyler Stewart, MD, University of California, San Diego, CA, comments on results from the Phase III KEYNOTE-B15 trial (NCT04700124) evaluating neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab versus neoadjuvant cisplatin-based chemotherapy in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC). The combination significantly improved event-free survival, overall survival, and pathological complete response rates compared to standard chemotherapy. These findings support the use of this perioperative regimen as an effective treatment option, demonstrating superior efficacy over traditional neoadjuvant chemotherapy followed by surgery. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
The KEYNOTE-B15 study is a study for patients with muscle-invasive bladder cancer who are cis-eligible and are planning to undergo cystectomy. In the past, these patients have received cisplatin-based chemotherapy and then undergone cystectomy. And more recently, we’ve also added immune checkpoint inhibitors in this setting, either in the perioperative or in the adjuvant setting...
The KEYNOTE-B15 study is a study for patients with muscle-invasive bladder cancer who are cis-eligible and are planning to undergo cystectomy. In the past, these patients have received cisplatin-based chemotherapy and then undergone cystectomy. And more recently, we’ve also added immune checkpoint inhibitors in this setting, either in the perioperative or in the adjuvant setting. More recently, EV pembro has become the standard of care for patients in the metastatic setting, and we’ve seen great data for cis-ineligible patients who are going to undergo cystectomy. This study looked at EV-Pembrolizumab in the perioperative setting versus cis-GEM neoadjuvantly. So what we see in this study is that perioperative pembrolizumab and not infortimab-vedotin showed a significant improvement in event-free survival and overall survival with really remarkable pathologic complete response rates. 56% in the entire EV Pembrolizumab cohort, 64% of the patients who underwent surgery. So really remarkable. And this study probably changes the landscape and puts EVP as the standard of care for most patients with muscle-invasive bladder cancer who are going to undergo cystectomy.
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