This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk

A New Era in MIBC Care

NOW APPROVED in the UK: The IMFINZI NIAGARA regimen* – the FIRST and ONLY perioperative IO regimen approved in the UK for your cisplatin-eligible, resectable MIBC patients^1,2

Indication: IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable MIBC¹

Despite current MIBC treatment options, survival and recurrence outcomes remain limited, and IO treatments are restricted to selected patients post radical cystectomy^3-6

of patients who received neoadjuvant gem-cis + RC experienced recurrence within 3 years^3,5,†

of patients who received neoadjuvant gem-cis + RC died within 5 years^3,5,‡

Current IO therapies are limited to the adjuvant setting in PD-L1 positive patients at high risk of recurrence post-RC who are not suitable for adjuvant platinum chemotherapy⁶

†In a comparison of clinical outcomes in patients with localised or locally advanced UC treated with neoadjuvant gem-cis (n=176) and high dose-intensity MVAC (n=41), the 3-year DFS was 54.9% in the gem-cis arm vs 63.2% in the high dose-intensity MVAC arm (P=0.21). Additionally, in a randomised Phase III study of ddMVAC vs gem-cis in patients with MIBC, progression was observed during the first 3 years of follow-up in 96 patients (44%) who received neoadjuvant (n=219) or adjuvant (n=26) gem-cis vs 69 patients (36%) who received ddMVAC (n=248) (HR=0.77; 95% CI, 0.57 to 1.02; P=0.066).^3-5

 ‡In a 5-year analysis of neoadjuvant ddMVAC vs gem-cis, 5-year OS (secondary endpoint) was 57% in the gem-cis arm vs 66% in the ddMVAC arm (HR=0.71; 95% CI, 0.52-0.97).⁵

Redefine treatment in MIBC with the perioperative IMFINZI NIAGARA regimen*: the FIRST and ONLY perioperative IO regimen approved in the UK for your cisplatin-eligible, resectable MIBC patients^1,2

Unrestricted by PD-L1, the perioperative IMFINZI NIAGARA regimen*  offers the joint uro-oncology team a new opportunity to potentially overcome the limitations of current treatment options²

Explore key efficacy and safety data from the NIAGARA trial

*The perioperative IMFINZI NIAGARA regimen is defined as neoadjuvant IMFINZI + gem-cis followed by adjuvant IMFINZI as a single agent after RC^1,2

MIBC, muscle-invasive bladder cancer; IO, immuno-oncology; gem-cis, gemcitabine-cisplatin; PD-L1, programmed death-ligand 1; RC, radical cystectomy; UC, urothelial carcinoma; ddMVAC, dose-dense methotrexate, vinblastine, doxorubicin and cisplatin; HR, hazard ratio; CI, confidence interval.

IMFINZI, Summary of Product Characteristics.
Powles T, et al. N Engl J Med. 2024;391(19):1773-1786 (including Supplementary Appendix and Protocol).
Lee Y et al. J Cancer Res Clin Oncol. 2021;147(11):3421-3429.
Pfister C, Gravis G, Fléchon A, et al. J Clin Oncol. 2022;40(18):2013-2022.
Pfister C, Gravis G, Fléchon A, et al. Lancet Oncol. 2024;25(2):255-264.
NICE (2022) Nivolumab for adjuvant treatment of invasive urothelial cancer at high risk of recurrence. Available at: https://www.nice.org.uk/guidance/ta817 (Accessed: August 2025).
Versluis JM, Long GV, Blank CU. Nat Med. 2020;26(4):475-484.
Lao CD et al. Am Soc Clin Oncol Educ Book. 2022;42:738-744.
Janjigian YY, Wolchok JD, Ariyan CE. Cancer Cell. 2021;39(6):738-742.
Aaes TL, Vandenabeele P. Cell Death Differ. 2021;28(3):843-860.

GB-67155 | October 2025

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A New Era in MIBC Care

Despite current MIBC treatment options, survival and recurrence outcomes remain limited, and IO treatments are restricted to selected patients post radical cystectomy3-6

Redefine treatment in MIBC with the perioperative IMFINZI NIAGARA regimen*: the FIRST and ONLY perioperative IO regimen approved in the UK for your cisplatin-eligible, resectable MIBC patients1,2

Unrestricted by PD-L1, the perioperative IMFINZI NIAGARA regimen* offers the joint uro-oncology team a new opportunity to potentially overcome the limitations of current treatment options2

Abbreviations and References

Despite current MIBC treatment options, survival and recurrence outcomes remain limited, and IO treatments are restricted to selected patients post radical cystectomy^3-6

Redefine treatment in MIBC with the perioperative IMFINZI NIAGARA regimen*: the FIRST and ONLY perioperative IO regimen approved in the UK for your cisplatin-eligible, resectable MIBC patients^1,2

Unrestricted by PD-L1, the perioperative IMFINZI NIAGARA regimen*  offers the joint uro-oncology team a new opportunity to potentially overcome the limitations of current treatment options²