Katy Beckermann, Medical Director of GU Clinical Research at Tennessee Oncology, shared on LinkedIn:
“Perioperative EV plus pembrolizumab is now approved for every muscle invasive bladder cancer (MIBC) patient headed for cystectomy, cisplatin-eligible or not.
- KEYNOTE-B15/EV-304: 808 cisplatin-eligible patients, perioperative EV + pembro vs neoadjuvant gemcitabine + cisplatin
- All candidates for radical cystectomy with pelvic lymph node dissection
- EFS: HR 0.53 (median not reached vs 48.5 mo), p<0.0001
- OS: HR 0.65, p=0.0029
- Safety consistent with prior EV + pembro: skin, hyperglycemia, pneumonitis, neuropathy, ocular
This is the first perioperative regimen to beat cisplatin-based chemotherapy on survival in eligible MIBC. For 20 years, neoadjuvant gem/cis was the standard every new approach was measured against.
OS medians are not yet reached in either arm, so that curve will keep maturing but the direction is already clear.”

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