AstraZeneca Releases Positive Phase 3 Results for Imfinzi in Bladder Cancer

AstraZeneca recently announced encouraging outcomes from a thorough analysis of its Imfinzi (durvalumab) treatment in people with muscle-invasive bladder cancer (MIBC). The results come from the phase 3 NIAGARA trial, which examined the effects of a perioperative treatment regimen involving Imfinzi combined with neoadjuvant chemotherapy before bladder removal surgery, known as cystectomy. This was compared to a treatment plan involving neoadjuvant chemotherapy alone prior to surgery, without any subsequent treatment.

Worldwide, over 614,000 individuals receive a diagnosis for bladder cancer annually. MIBC, characterized by cancer growth into the bladder’s muscle wall, constitutes roughly 25% of these cases. Despite undergoing standard cystectomy procedures, about half of MIBC patients face disease recurrence.

Earlier reports highlighted that the combination of Imfinzi with chemotherapy resulted in significant improvements in both event-free survival (EFS) and overall survival (OS) in comparison to neoadjuvant chemotherapy alone. These findings were important markers of success in the NIAGARA trial.

The latest insights, revealed during the American Society of Clinical Oncology Genitourinary Cancers Symposium, highlight that AstraZeneca's treatment regimen significantly reduced the risk of several adverse outcomes. For patients who achieved a pathologic complete response (pCR), it reduced the risk of disease progression, recurrence, surgery avoidance, or death by 42%. For those who did not achieve pCR, the risk was reduced by 23%. Additionally, the risk of death was lowered by 28% in the pCR group and by 16% in those without a pCR.

The Imfinzi regimen also demonstrated a 33% reduction in the risk of developing distant metastases or death and a 31% decrease in the risk of death attributed specifically to bladder cancer. These are significant secondary endpoints that favor the combination treatment over the comparator arm.

Imfinzi is already approved for use in various other cancers, including those affecting the lungs, biliary tract, endometrium, and liver. As a potential new standard of care for MIBC, the perioperative use of Imfinzi combined with neoadjuvant chemotherapy is under priority review by the US Food and Drug Administration. Regulatory submissions for this treatment protocol are also being evaluated across the European Union and several other nations, based on the NIAGARA study’s findings.

Cristian Massacesi, AstraZeneca's chief medical officer and oncology development leader, remarked on the significance of the NIAGARA trial. He noted that it is the first phase 3 study to demonstrate substantial and meaningful improvements in EFS and OS through a perioperative immunotherapy approach in MIBC. He also emphasized how the 33% reduction in the risk of distant metastases, conditions typically linked with poorer outcomes, underscores the potential of this treatment strategy to become a new standard of care for patients suffering from this cancer type.