Company: AZN
Filing Date: 2025-05-27
Form Type: 6-K
Source: 0001654954-25-006101
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-05-27
Form: 6-K
Chunk 2
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 patients at two years after treatment. This supports our strategy of moving our innovative medicines into the earlier stages of disease where the opportunity for treatment with curative intent is greatest. If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting."

In 2024, over 35,000 people in the five major European countries were treated for MIBC. 1 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases. 2 Despite this representing a curative-intent setting, where the current standard-of-care is neoadjuvant chemotherapy and radical cystectomy, many patients experience disease recurrence after surgery and have a poor prognosis. 3

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events were consistent with the known profile of Imfinzi , manageable and mostly low-grade.

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications are currently under review in Japan and several other countries.

#### Notes

#### Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year. 4 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract. 2 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence. 3 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

#### NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy , or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting