KEYNOTE-866: Perioperative pembrolizumab did not significantly improve event-free survival in cisplatin-eligible MIBC
Phase 3 RCT · Ann Oncol · 2026-10-24. Number 1 in the UrologyWatch Top 5 for October 24, 2026.
In this phase 3 trial of 907 cisplatin-eligible MIBC patients, adding perioperative pembrolizumab to neoadjuvant cisplatin-gemcitabine did not significantly improve 5-year event-free survival (63.5% vs 61.9%, HR 0.88) despite a higher pathologic complete response rate (44.4% vs 35.8%).
Why it matters: Contrasts with other perioperative immunotherapy regimens that have shown benefit in MIBC, highlighting that pCR gains do not always translate to survival benefit.
Limitation: One-sided statistical testing; despite pCR improvement, the primary endpoint of event-free survival was not met.
Source: Ann Oncol · PubMed 42918422 · DOI 10.1016/j.annonc.2026.10.106
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