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NIAGARA Trial Efficacy Data

Understanding IMFINZI treatment for your patients with resectable muscle-invasive bladder cancer (MIBC)

PrIMFINZI® (durvalumab) is indicated for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant IMFINZI monotherapy treatment after radical cystectomy.1.2

Be IN the know with IMFINZI’s NIAGARA EFS data

NIAGARA Primary endpoint:1

Event-free survival (EFS) by BICR*

* Defined as the time from randomization to progressive disease that precluded radical cystectomy, the first recurrence of disease after radical cystectomy, the expected date of surgery (in patients who did not undergo radical cystectomy), or death from any cause.2 

† Based on stratified log-rank test with tumour stage [T2N0 vs. >T2N0], renal function [adequate vs. borderline], and PD-L1 status [high vs. low/negative] as stratification factors. 

‡ The boundaries for declaring statistical significance for the primary efficacy endpoints, EFS and the key secondary endpoint OS were determined by a multiple test procedure with an alpha-exhaustive recycling strategy. Alpha allocated to EFS and OS at the second interim analysis was based on a Lan-DeMets alpha spending function with O'Brien Fleming approach (EFS = 0.0412, OS = 0.0154, 2-sided). 

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Be IN the know with IMFINZI’s NIAGARA OS data

NIAGARA Secondary endpoint:1

Overall Survival (OS)

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IMFINZI NIAGARA—demonstrated surgical data (other endpoint)

NIAGARA Other endpoint:1

Surgical data

IMFINZI is indicated for the treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant IMFINZI monotherapy treatment after radical cystectomy.

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§ NIAGARA was a phase III, open-label trial of adult patients with resectable MIBC who had not received prior systemic chemotherapy or immune-mediated therapy for the treatment These patients were randomized to either neoadjuvant IMFINZI (1500 mg Day 1) combined with gemcitabine (1000 mg/m2 Days 1 & 8) and cisplatin (70 mg/m2 Day 1) every 3 weeks for 4 cycles, followed by adjuvant IMFINZI monotherapy (1500 mg every 4 weeks for up to 8 cycles) (n=533) or neoadjuvant gemcitabine (1000 mg/m2 Days 1 & 8) and cisplatin (70 mg/m2 Day 1) every 3 weeks for 4 cycles (n=530). Patients with CrCl ≥40 to <60 mL/min received split-dose cisplatin (35 mg/m2 Days 1 & 8).

References:

  1. IMFINZI Product Monograph. AstraZeneca Canada Inc. January 22, 2026.
  2. Powles T, Catto JWF, Galsky MD, et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391(19):1773-1786.

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