AstraZeneca's Imfinzi Secures EU Approval for Perioperative Treatment of Muscle-Invasive Bladder Cancer Following Landmark NIAGARA Trial

The press release pointed out that this isThe First and Only Perioperative Immunotherapy for Patients with Muscle-Invasive Bladder Cancer。

This approval is based on the results of the NIAGARA III clinical trial. This is aResults of the multicenter, global Phase III trial NIAGARA. The trial aimed to evaluateEfficacy of Perioperative Treatment with Durvalumab in Patients with MIBC Undergoing Radical Cystectomy。

In the trial, 1063 patients were randomly assigned to receiveDurvalumab plus neoadjuvant chemotherapy, followed by cystectomy, or neoadjuvant chemotherapy alone before cystectomy, with no further treatment required postoperatively.The dual primary endpoints of the study are event-free survival（EFS）AndPathological Complete Response at the Time of Cystectomy (pCR)。

NIAGARA Study Data Presented at the 2024 European Society for Medical Oncology (ESMO)Announced at the conference and simultaneously published in The New England Journal of Medicine.

Mid-term analysis data show that, compared with neoadjuvant chemotherapy alone, the perioperative regimen based on durvalumab,Reduced the risk of disease progression, recurrence, non-surgery, or death by 32%(Based on EFS Hazard Ratio [HR] of 0.68; 95% Confidence Interval [CI] 0.56-0.82; p<0.0001)The estimated median EFS in the durvalumab group has not been reached, while it was 46.1 months in the control group. Among the patients treated with this regimen,An estimated 67.8% were event-free at two years, while the control group was 59.8%.

The results of the key secondary endpoint OS indicate that, compared with neoadjuvant chemotherapy for radical cystectomy, the perioperative regimen based on durvalumab...Can reduce the risk of death by 25%(Based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). The median survival time for both groups has not been reached. It is estimated that those receiving82.2% of patients treated with durvalumab regimen survived within two years, compared to 75.2% in the control group.

Durvalumab was generally well tolerated, with no new safety signals observed in either the neoadjuvant or adjuvant setting. Moreover, adding durvalumab to neoadjuvant chemotherapy is consistent with the known profile of this combination and does not compromise patients' ability to complete surgery compared with neoadjuvant chemotherapy alone. Immune-mediated adverse events were consistent with the known profile of durvalumab, manageable, and mostly low-grade.

Based on the results of the NIAGARA trial,DurvalumabIt has been approved for such treatment in the United States and other countries. Currently, Japan and several other countries are reviewing the registration application for this indication.

In addition, DurvalumabAlso based on the results of the PACIFIC and AEGEAN Phase III clinical trials, it has gained approval in other treatment settings aimed at cure, for the treatment of non-small cell lung cancer.（NSCLC）; Based on the results of the ADRIATIC Phase III clinical trial,DurvalumabHas also been approved for the treatment of limited-stage small cell lung cancer.（SCLC）。

Since it was first approved,DurvalumabSales have been rising all the way. In 2024Global sales reached $4.717 billion, a year-on-year increase of 11.33%.。Q1 2025,DurvalumabHas achieved$12.21 billion, an increase of 16% year-on-year, ranking among the top three revenue-generating products in AstraZeneca's portfolio.

Screenshot source: Insight database