Event-free and progression-free survival fall short as OS surrogates in BCG-naive HR-NMIBC

Retrospective · World J Urol · 2026-10-03. Number 1 in the UrologyWatch Top 5 for October 5, 2026.

An 18-center study of 3,384 patients with BCG-naive high-risk NMIBC found adequate BCG exposure improved overall survival, but pseudo-trial-level surrogacy for OS was moderate (R2 0.60 for PFS, 0.51 for EFS), below the prespecified adequacy threshold.

Why it matters: Raises caution about relying on EFS or PFS as primary endpoints in NMIBC immunotherapy trials without OS confirmation.

Source: World J Urol · PubMed 42823574 · DOI 10.1016/j.euo.2026.06.006

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