Final CA017-078 results: perioperative nivolumab plus chemo did not improve event-free survival in MIBC
Phase 3 RCT · Ann Oncol · 2026-10-24. Number 2 in the UrologyWatch Top 5 for October 24, 2026.
In this phase 3 trial of 653 patients with resectable MIBC, neoadjuvant nivolumab plus gemcitabine-cisplatin followed by adjuvant nivolumab improved pathologic complete response (39.1% vs 29.6%) but did not improve event-free survival compared to chemotherapy alone (HR 0.94) at a median follow-up of 54.5 months.
Why it matters: Adds to a mixed body of phase 3 evidence on perioperative checkpoint inhibition in MIBC, where pCR gains have not uniformly translated into event-free survival benefit.
Limitation: Formal survival testing was contingent on a significant EFS result, which was not met, so OS findings are descriptive only.
Source: Ann Oncol · PubMed 42918420 · DOI 10.1016/j.annonc.2026.10.096
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