In the NIAGARA study:
Perioperative IMFINZI + neoadjuvant gem-cis significantly improved EFS and OS
vs neoadjuvant gem-cis1,2*
*EVENT-FREE SURVIVAL (dual primary endpoint, ITT population)1,2†
REDUCTION IN RISK OF AN EVENT
(progression, recurrence, death, or not undergoing RC) with the NIAGARA regimen vs neoadjuvant gem-cis (HR 0.68, 95% CI 0.56-0.82, p<0.0001)
An event occurred in 35.1% of patients (n=187/533) treated with the NIAGARA regimen vs 46.4% of patients (n=246/530) treated with neoadjuvant gem-cis. Median EFS was not reached with the NIAGARA regimen (95% CI NR-NR) vs 46.1 months with neoadjuvant gem-cis (95% CI 32.2-NR); median duration of follow-up: 42.3 months; dual primary endpoints for the NIAGARA study were pCR assessed by BICR and EFS assessed by BICR or by CPR if a biopsy was needed for analysis of a suspected new lesion1,2
*OVERALL SURVIVAL (secondary endpoint, ITT population)1,2†
REDUCTION IN RISK OF DEATH
with the NIAGARA regimen vs neoadjuvant gem-cis (HR 0.75, 95% CI 0.59-0.93, p=0.01)
An event occurred in 25.5% of patients (n=136/533) treated with the NIAGARA regimen vs 31.9% of patients (n=169/530) treated with neoadjuvant gem-cis. Median OS was not reached with the NIAGARA regimen (95% CI NR-NR) nor with neoadjuvant gem-cis (95% CI NR-NR); median duration of follow-up: 46.3 months1,2
Studied across a broad population of cis-eligible MIBC patients
including those with PD-L1 low/negative status, borderline renal function (CrCl ≥40 mL/min to <60 mL/min) and N1 involvement2
The safety profile of the NIAGARA regimen was consistent with the individual safety profiles for IMFINZI and gem-cis2
†Based on a pre-specified interim analysis (DCO April 29, 2024).2
In the NIAGARA study for MIBC:
Perioperative IMFINZI + neoadjuvant gem-cis significantly improved EFS
vs neoadjuvant gem-cis1,2*
*EVENT-FREE SURVIVAL (dual primary endpoint, ITT population)1,2†
REDUCTION IN RISK OF AN EVENT
(progression, recurrence, death, or not undergoing RC) with the NIAGARA regimen vs neoadjuvant gem-cis (HR 0.68, 95% CI 0.56-0.82, p<0.0001)
An event occurred in 35.1% of patients (n=187/533) treated with the NIAGARA regimen vs 46.4% of patients (n=246/530) treated with neoadjuvant gem-cis. Median EFS was not reached with the NIAGARA regimen (95% CI NR-NR) vs 46.1 months with neoadjuvant gem-cis (95% CI 32.2-NR); median duration of follow-up: 42.3 months; dual primary endpoints for the NIAGARA study were pCR assessed by BICR and EFS assessed by BICR or by CPR if a biopsy was needed for analysis of a suspected new lesion1,2
pCR (dual primary endpoint, ITT population)2
- At the primary analysis (DCO January 14, 2022), 33.8% (n=180/533; 95% CI 29.8-38.0) of patients treated with the NIAGARA regimen and 25.8% (n=137/530; 95% CI 22.2-29.8) of patients treated with neoadjuvant gem-cis achieved a pCR; pCR rates reported during the primary analysis did not reach statistical significance
- At the exploratory re-analysis (DCO April 29, 2024), 37.3% (n=199/533; 95% CI 33.2-41.6) of patients treated with the NIAGARA regimen and 27.5% (n=146/530; 95% CI 23.8-31.6) of patients treated with neoadjuvant gem-cis achieved a pCR. The re-analysis included an additional 59 patients that were mistakenly omitted from the primary analysis. The re-analysis was exploratory and not powered to determine statistical significance
In the NIAGARA study for MIBC:
Perioperative IMFINZI + neoadjuvant gem-cis significantly improved OS
vs neoadjuvant gem-cis1,2*
*OVERALL SURVIVAL (secondary endpoint, ITT population)1,2†
REDUCTION IN RISK OF DEATH
with the NIAGARA regimen vs neoadjuvant gem-cis (HR 0.75, 95% CI 0.59-0.93, p=0.01)
An event occurred in 25.5% of patients (n=136/533) treated with the NIAGARA regimen vs 31.9%% of patients (n=169/530) treated with neoadjuvant gem-cis. Median OS was not reached with the NIAGARA regimen (95% CI NR-NR) nor with neoadjuvant gem-cis (95% CI NR-NR); median duration of follow-up: 46.3 months1,2
In the NIAGARA study for MIBC:
Time to RC after neoadjuvant treatment was similar between treatment arms2*
NIAGARA: Phase III study in >1000 cis-eligible MIBC patients2
Arm 1: IMFINZI 1500 mg + gem 1000 mg/m2 and cis 70 mg/m2 on Day 1, then gem 1000 mg/m2 on Day 8, Q3W for 4 cycles prior to surgery, followed by IMFINZI 1500 mg Q4W for up to 8 cycles after surgery. Arm 2: gem 1000 mg/m2 and cis 70 mg/m2 on Day 1, then gem 1000 mg/m2 on Day 8, Q3W for 4 cycles prior to surgery, without post-surgery treatment.2 The dual primary endpoints were pCR assessed by BICR and EFS assessed by BICR or by CPR if a biopsy was needed for analysis of a suspected new lesion. EFS was defined as the time from randomisation to first recurrence of disease post-RC, time to first documented progression in patients who were precluded from RC, time of expected surgery in patients who refused RC or failure to undergo RC due to residual disease, or death due to any cause, whichever occurs first. The key secondary endpoint was OS as assessed with an alpha-allocation approach, following EFS in the statistical hierarchy. The study was not designed to isolate the relative contributions of each treatment phase to the efficacy outcomes.2
In the NIAGARA study for MIBC:
The safety profile of the NIAGARA regimen was consistent with the individual safety profiles for IMFINZI and gem-cis2
Please see Product Information for additional safety information.
In the NIAGARA study for MIBC:
The safety profile of the NIAGARA regimen was consistent with the individual safety profiles for IMFINZI and gem-cis2
Please see Product Information for additional safety information.
NIAGARA regimen for MIBC:
Start with neoadjuvant IMFINZI + gem-cis, then continue with adjuvant IMFINZI monotherapy1
IMFINZI dosage for patients with a body weight of ≥30 kg1
- Continue IMFINZI until disease progression that precludes definitive surgery, recurrence, unacceptable toxicity, or a maximum of 8 cycles after surgery1
- Patients with a body weight of ≤30 kg must receive weight-based dosing of IMFINZI at 20 mg/kg. In combination with chemotherapy, dose at 20 mg/kg Q3W (21 days) prior to surgery, followed by monotherapy at 20 mg/kg Q4W after surgery until weight increases to >30 kg1
- When IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day1
Please see Product Information for additional safety information.
PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342.
AE, adverse event; BICR, blinded independent central review; cis, cisplatin; CI, confidence interval; CPR, central pathology review; CrCl, creatinine clearance; CTAE, Common Terminology Criteria for Adverse Events; DCO, data-cutoff; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; gem-cis, gemcitabine-cisplatin; GI, gastrointestinal; HR, hazard ratio; IO, immunotherapy; ITT, intention to treat; MIBC, muscle invasive bladder cancer; N1, cancer cells in 1-2 nearby lymph nodes; NR, not reached; OS, overall survival; pCR, pathological complete response; PD-L1, programmed death-ligand 1; Q3W, every 3 weeks; Q4W, every 4 weeks; RC, radical cystectomy; UC, urothelial carcinoma.
References: 1. IMFINZI® (durvalumab) Approved Product Information. 2. Powles T et al. N Engl J Med 2024;391(19):1773-1786 (including Supplementary Appendix).
IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com.