Imfinzi (durvalumab), a novel perioperative treatment for adult patients with resectable muscle-invasive bladder cancer (MIBC), has received approval from the European Commission. A new standard of care for patients with a high risk of recurrence is provided by this first-of-its-kind approval in the European Union, which combines Imfinzi with chemotherapy before to surgery and Imfinzi as a single agent following surgery.
The NIAGARA Phase III trial, a worldwide research that showed a significant 32% reduction in the risk of cancer progression, recurrence, or mortality for patients treated with the Imfinzi regimen compared to neoadjuvant chemotherapy alone, served as the basis for the approval. There was also a 25% decrease in the chance of death, according to trial data that was published in The New England Journal of Medicine. Compared to 75.2% of patients in the control group, 82.2% of patients who received the Imfinzi-based treatment were still alive at the two-year period.
The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder. The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting.
Dr Michiel Van der Heijden
Muscular-invasive bladder cancer is the stage at which the tumor has pierced the bladder’s muscular wall, making bladder cancer the ninth most frequent type of cancer worldwide. Many individuals have a recurrence of their cancer even though surgery and chemotherapy are intended to treat it. This important unmet need is directly addressed by this innovative immunotherapy regimen with Imfinzi.
By giving the NIAGARA regimen the highest possible grade of “A” on the Magnitude of Clinical Benefit Scale for curative-intent medicines, the European Society for Medical Oncology (ESMO) has highlighted the clinical merit of this novel treatment.
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The safety profile of imfinzi was found to be in line with earlier research, and it was generally well tolerated. Patients’ capacity to have surgery was unaffected by the addition of Imfinzi to chemotherapy.
Japan and other nations are currently conducting regulatory reviews, and this EU clearance comes after a similar authorization in the US. Imfinzi is being researched for a variety of other cancers and is a crucial treatment in AstraZeneca’s portfolio for several types of lung cancer.
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