LONDON (dpa-AFX) - AstraZeneca Plc (AZN.L, AZN) announced that the NIAGARA Phase III trial showed its IMFINZI (durvalumab) in combination with chemotherapy led to a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) compared to neoadjuvant chemotherapy alone. Patients were treated with IMFINZI and chemotherapy before radical cystectomy, followed by IMFINZI as adjuvant monotherapy.
In a planned interim analysis, patients treated with the IMFINZI perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm. Estimated median EFS was not yet reached for IMFINZI arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the IMFINZI regimen were event free at two years compared to 59.8% in the comparator arm.
The company noted that results from the key secondary endpoint of overall survival showed the IMFINZI perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy. Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the IMFINZI regimen were alive at two years compared to 75.2% in the comparator arm.
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