Enfortumab Vedotin Plus Pembrolizumab Improves Outcomes in Muscle-Invasive Bladder Cancer in KEYNOTE-B15/EV-304
Key Points
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In the KEYNOTE-B15/EV-304 trial, perioperative enfortumab vedotin (EV) plus pembrolizumab significantly improved outcomes in patients with muscle-invasive bladder cancer (MIBC).
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The combination showed better event-free survival (EFS) and overall survival (OS) rates compared with standard neoadjuvant gemcitabine plus cisplatin followed by surgery.
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The phase 3 study demonstrated significant improvements in pathologic complete response (pCR) with EV-pembrolizumab versus chemotherapy (55.8% vs 32.5%).
Data from the KEYNOTE-B15/EV-304 trial, presented at the 2026 ASCO Genitourinary Cancers Symposium, highlight enfortumab vedotin plus pembrolizumab as a potential new standard of care for cisplatin-eligible muscle-invasive bladder cancer. Co-hosts of the Oncology Brothers podcast, Rahul Gosain, MD, MBA, of Wilmot Cancer Institute, and Rohit Gosain, MD, of Roswell Comprehensive Cancer Center, discussed the clinically meaningful findings and the implications for community oncologists.
In the perioperative setting, the combination improved EFS and OS compared with gemcitabine-cisplatin followed by surgery. At 24 months, EFS was 79.4% with EV-pembrolizumab versus 66.2% with chemotherapy, and OS was 86.9% versus 81.3%, respectively. Moreover, significant improvements in pCR were observed, with a rate of 55.8% in the EV-pembrolizumab arm compared with 32.5% in the chemotherapy arm.
Patients with MIBC received EV-pembrolizumab every 3 weeks for 4 cycles in the neoadjuvant setting before radical cystectomy, followed by an additional 5 cycles of EV with ongoing pembrolizumab.
“Moving forward, this is going to be your new treatment option for muscle-invasive bladder cancer,” said Dr. Rahul Gosain.