KEYNOTE-866: perioperative pembrolizumab with cisplatin-gemcitabine does not improve EFS in cisplatin-eligible MIBC

Phase 3 RCT · Urology Times · 2026-10-23. Number 1 in the UrologyWatch Top 5 for October 30, 2026.

In 907 cisplatin-eligible patients with MIBC (median follow-up 60.9 months), adding perioperative pembrolizumab to neoadjuvant cisplatin-gemcitabine did not significantly improve event-free survival (HR 0.88, 95% CI 0.71 to 1.10; 60-month EFS 63.5% vs 61.9%). pCR rose to 44.4% vs 35.8%, but OS was identical (HR 1.00). Grade 3 to 5 adverse events were 80.2% vs 75.1%.

Why it matters: Perioperative pembrolizumab with cisplatin-gemcitabine is not supported for cisplatin-eligible MIBC.

Limitation: Placebo-controlled; PD-L1 subgroups showed no clear benefit.

Source: Urology Times · PubMed 42918422 · DOI 10.1016/j.annonc.2026.10.106

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