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AstraZeneca PLC (NASDAQ:AZN) announced Monday that the European Commission has approved Imfinzi (durvalumab) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC). The approval allows Imfinzi to be used in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy after radical cystectomy.
The decision is based on results from the NIAGARA Phase III trial, which showed that the Imfinzi-based regimen led to a statistically significant 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death compared to neoadjuvant chemotherapy with radical cystectomy alone. The hazard ratio for event-free survival was 0.68 (95% confidence interval 0.56-0.82; p<0.0001). At two years, an estimated 67.8% of patients treated with the Imfinzi regimen were event free, compared to 59.8% in the comparator arm.
Secondary analysis from the trial indicated a 25% reduction in the risk of death for patients receiving the Imfinzi-based regimen, with a hazard ratio for overall survival of 0.75 (95% CI 0.59-0.93; p=0.0106). At two years, 82.2% of patients in the Imfinzi group were alive, compared to 75.2% in the comparator group. Median survival had not been reached for either group at the time of analysis.
The European Society for Medical (TASE:BLWV) Oncology (ESMO) assessed the NIAGARA regimen and awarded it a grade of "A" on its Magnitude of Clinical Benefit Scale in the curative setting.
Imfinzi was generally well tolerated in the trial, with no new safety signals reported. The safety profile was consistent with previous studies of Imfinzi.
In 2024, over 35,000 people in five major European countries were treated for MIBC. Bladder cancer is the ninth most common cancer worldwide, with more than 614,000 diagnoses each year.
This information is based on a statement in a press release filed with the U.S. Securities and Exchange Commission.
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