Pts aged ≥ 18 y with mUC, susceptible FGFRa and measurable disease (no prior systemic therapy for mUC, cis-ineligible) were randomized 1:1 to once-daily ERDA 8 mg (with pharmacodynamically guided uptitration (UpT) to 9 mg) or ERDA 8 mg (no UpT) + IV CET 240 mg...4 pts in each arm were PD-L1 positive. 3/4 (75%) PD-L1 positive pts responded to ERDA+CET vs 0 for ERDA….Combination ERDA+CET demonstrated clinically meaningful activity and was well tolerated.