. Author manuscript; available in PMC: 2026 Apr 30.

Published in final edited form as: Clin Cancer Res. 2026 Apr 15;32(8):1383–1388. doi: 10.1158/1078-0432.CCR-25-3609

Table 1:

Efficacy Results in NIAGARA

	Durvalumab plus gemcitabine and cisplatin (N=533)	Gemcitabine and cisplatin (N = 530)
EFS ^*
Number of events (%)	187 (35.1)	246 (46.4)
Median EFS (months) (95% CI)	NR (NR, NR)	46.1 (32.2, NR)
HR (95% CI)^†	0.68 (0.56, 0.82)
2-sided p-value^§,#	<0.0001
Overall Survival (OS)
Number of events (%)	136 (25.5)	169 (31.9)
Median OS (months) (95% CI)	NR (NR, NR)	NR (NR, NR)
HR (95% CI)^†	0.75 (0.59, 0.93)
2-sided p-value^§,#	0.0106

Source: table adapted from the label (8); there are no restrictions on its use

Even Free Survival (EFS) is defined as the time from randomization to the first recurrence of disease after radical cystectomy, the time of first documented progression in patients who are medically precluded from a radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first.

^†

Based on stratified Cox proportional hazard model.

^§

Based on stratified log-rank test.

Alpha allocated at the interim analysis was 0.0412 for EFS and 0.0154 for OS.

CI = Confidence Interval, HR = Hazard Ratio, NR = Not Reached