Company: AZN
Filing Date: 2025-05-27
Form Type: 6-K
Source: 0001654954-25-006101
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-05-27
Form: 6-K
Chunk 1
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vant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the NIAGARA Phase III trial, which were presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine .

In a planned interim analysis, the Imfinzi -based perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi -based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy alone (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: "Approximately half of patients with muscle-invasive bladder cancer will experience disease recurrence despite curative-intent treatment with neoadjuvant chemotherapy and surgery to remove the bladder. This recommendation for the durvalumab-based perioperative regimen brings us closer to providing an important new treatment option that has demonstrated a significant survival benefit, with the potential to transform the treatment approach for patients across Europe."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The Imfinzi -based perioperative regimen in the NIAGARA Phase III trial enabled survival of more than 80 per cent of