Imfinzi Shows Promising Results in Muscle-Invasive Bladder Cancer

Treatment with Imfinzi (durvalumab) before and after surgery was found to improve both event-free survival (the time after treatment that a patient’s disease does not worsen) and overall survival (the time a patient lives following treatment, regardless of disease status) in patients with muscle-invasive bladder cancer, according to a recent announcement.

The drug manufacturer AstraZeneca has released high-level results from the phase 3 NIAGARA trial, stating that the improvements in event-free survival and overall survival were “statistically significant and clinically meaningful.”

The NIAGARA trial includes 1,063 patients with muscle-invasive bladder cancer being treated at nearly 200 sites across the world. It is estimated to be completed in June 2026, according to its listing on clinicaltrials.gov.

Learn more: Evolution and Revolution in Bladder Cancer Treatment

Imfinzi is a monoclonal antibody, a type of treatment that binds to the PD-L1 protein, blocking the interaction of the PD-1 and CD80 proteins. In doing so, it counters cancer’s ability to evade the immune system, according to AstraZeneca.

According to the National Cancer Institute, Imfinzi is currently approved to treat adults with cancers including biliary tract cancer, endometrial cancer, hepatocellular carcinoma (a type of liver cancer), non-small cell lung cancer and small cell lung cancer.

Muscle-invasive bladder cancer occurs when tumors grow into or through the muscle wall of the bladder and occurs in approximately 25% to 30% of bladder tumors, according to the Bladder Cancer Advocacy Network. The American Cancer Society estimates that there will be approximately 83,190 new cases of bladder cancer in the United States in 2024.

“The NIAGARA results support our strategy to move immunotherapy to the early stages of cancer treatment,” stated Susan Galbraith, executive vice president, Oncology R&D for AstraZeneca, in the news release. “This perioperative [administered before and after surgery] regimen with Imfinzi improved survival and reduced the rate at which patients experience disease recurrence or progression.”

Patients participating in NIAGARA either received treatment with Imfinzi in combination with neoadjuvant (presurgical) chemotherapy followed by cystectomy (surgical removal of the bladder) and then Imfinzi as an adjuvant (postsurgical) monotherapy or neoadjuvant chemotherapy, surgery and then no further treatment.

According to AstraZeneca, Imfinzi represents the first immunotherapy regimen administered before and after surgery found to extend survival among patients with bladder cancer. The manufacturer stated that the current standard of care for this patient population includes neoadjuvant chemotherapy and radical cystectomy.

“Nearly half of patients with muscle-invasive bladder cancer who receive standard of care still experience disease recurrence or progression. These NIAGARA data show for the first time that adding [Imfinzi] to chemotherapy before surgery followed by [Imfinzi] extends patients’ lives,” stated Dr. Thomas Powles, professor and director of Barts Cancer Centre (QMUL) in London and an investigator in the trial, in the news release.

During the NIAGARA trial, Imfinzi was found to be generally well-tolerated, with no new safety concerns reported to have been observed in the neoadjuvant or adjuvant settings.

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