AstraZeneca (AZ) has announced that its Imfinzi (durvalumab)-based perioperative regimen has been approved by the European Commission (EC) to treat resectable muscle-invasive bladder cancer (MIBC).
The drug has been authorised for use in combination with gemcitabine and cisplatin chemotherapy as a neoadjuvant treatment before bladder removal surgery (radical cystectomy), followed by Imfinzi as an adjuvant monotherapy after surgery.
More than 35,000 people in five major European countries were treated for MIBC in 2024. Despite undergoing radical cystectomy with curative intent, around half of MIBC patients experience disease recurrence, underscoring the need for treatment options that prevent disease recurrence after surgery.
The EC’s decision on Imfinzi, which makes it the first and only perioperative immunotherapy approved in the EU for MIBC, follows a recent recommendation from the European Medicines Agency’s human medicines committee.
In a planned interim analysis of the phase 3 NIAGARA trial, the Imfinzi regimen was found to reduce the risk of disease progression, recurrence, not undergoing surgery, or death by 32% compared to neoadjuvant chemotherapy with radical cystectomy alone.
The Imfinzi regimen also lowered the risk of death by 25% compared to neoadjuvant chemotherapy with radical cystectomy, and an estimated 82.2% of patients receiving AZ’s regimen were alive at two years compared to 75.2% in the comparator arm.
Dave Fredrickson, executive vice president, oncology haematology business unit, AZ, said: “Imfinzi is poised to transform the standard of care for MIBC in Europe as the first and only perioperative immunotherapy for these patients.
“In the NIAGARA phase 3 trial, more than 80% of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades.”
Beyond MIBC, Imfinzi is approved in the EU to treat certain cases of lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma.
Commenting on the latest approval for the drug, NIAGARA trial investigator, Michiel Van der Heijden, said: “The [Imfinzi]-based perioperative regimen is an important new treatment option for patients in Europe with MIBC, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder.”