AstraZeneca's Imfinzi Receives CHMP Positive Opinion for Perioperative Treatment of Muscle-Invasive Bladder Cancer in the EU

The press release pointed out that this isThe first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer。

Moreover, this CHMP recommendation is based on the results 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.

The interim 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 yet 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 to 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 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, the addition of 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.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby interrupting tumor immune escape strategies and restoring suppressed immune responses. The drug has currently been approved for 9 indications in the United States, 10 indications in the European Union, and 4 indications in China.

Since its initial approval, sales of Imfinzi have been on the rise. 2024Global sales reached $4.717 billion, a year-on-year increase of 11.33%.。In the first quarter of 2025, Imfinzi achieved$12.21 billion, a year-on-year increase of 16%, is one of the top three revenue-generating products in AstraZeneca's portfolio.

Screenshot source: Insight database