AstraZeneca (AZ) has announced that its Imfinzi (durvalumab)-based perioperative regimen has been recommended for approval by the European Medicines Agency’s human medicines committee to treat adults with resectable muscle-invasive bladder cancer (MIBC).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that Imfinzi be used 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.
The CHMP’s decision, which comes less than two months after the US Food and Drug Administration approved the Imfinzi regimen for the same indication, was supported by results from the late-stage NIAGARA study.
In a planned interim analysis, the Imfinzi regimen was found to reduce the risk of disease progression, recurrence, not undergoing surgery, or death by 32% compared to neoadjuvant chemotherapy alone before radical cystectomy.
AZ’s regimen also demonstrated a 25% reduction in the risk of death compared to neoadjuvant chemotherapy with radical cystectomy, and an estimated 82.2% of patients receiving the regimen were alive at two years compared to 75.2% in the comparator arm.
Over 614,000 people worldwide are diagnosed with bladder cancer every year, with MIBC accounting for approximately one in four cases. Despite undergoing radical cystectomy with curative intent, around half of MIBC patients experience disease recurrence after surgery.
Imfinzi is an immunotherapy that is already approved in the EU to treat certain cases of lung cancer, biliary tract cancer, endometrial cancer and hepatocellular carcinoma. If approved for this latest patient population, Imfinzi would become the first and only perioperative immunotherapy approved in the EU for MIBC.
Susan Galbraith, executive vice president, oncology haematology research and development, AZ, said: “The Imfinzi-based perioperative regimen in the NIAGARA phase 3 trial enabled survival of more than 80% of patients at two years after treatment… If approved, this novel approach will become a much-needed new treatment option for patients in Europe and could become the new standard of care in this setting.”
The European Commission will now review the CHMP’s recommendation as it makes a final decision on Imfinzi in this indication.