▎WuXiEdited by Kant Content Team

AstraZeneca announced that the supplemental Biologics License Application (sBLA) for its重磅 immunotherapy Imfinzi (durvalumab) has been accepted by the U.S. FDA and granted Priority Review for the treatment of patients with muscle-invasive bladder cancer (MIBC). The FDA is expected to make a decision on this application in the second quarter of 2025.

Muscle-Invasive Bladder Cancer (MIBC) refers to the condition where a tumor invades the bladder muscle layer but has not yet metastasized distantly. According to statistics, about one-quarter of bladder cancer patients are diagnosed with MIBC. Patients with MIBC typically receive treatment aimed at cure, including neoadjuvant chemotherapy and radical cystectomy. However, even after undergoing cystectomy, patients still face a high recurrence rate and poor prognosis.

In this trial, patients received radical cystectomy after treatment with Imfinzi combined with neoadjuvant chemotherapy, followed byReacceptImfinzi as a single-agent adjuvant therapy,Or undergo radical cystectomy after receiving only neoadjuvant chemotherapy. In the planned interim analysis,The Imfinzi perioperative treatment regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death (HR=0.68; 95% CI: 0.56-0.82; p<0.0001).The median event-free survival (EFS) in the Imfinzi group has not yet been reached, while it was 46.1 months in the control group. Estimates show that at two years,The event-free survival rate for patients treated with Imfinzi was 67.8%, compared to 59.8% in the control group.

Key secondary endpoint overall survival (OS) data showed,The Imfinzi perioperative regimen reduced the risk of death by 25% compared to the control group (HR=0.75; 95% CI: 0.59-0.93; p=0.0106).The median overall survival has not been reached in either group. Estimates show that at two years,Patients receiving Imfinzi regimen have82.2% Still Surviving, while the control group had a value of 75.2%.

Imfinzi was generally well-tolerated in both the neoadjuvant and adjuvant treatment phases, with no new safety signals identified. Furthermore, the addition of Imfinzi to the neoadjuvant chemotherapy regimen demonstrated a safety profile consistent with the individual drugs, without impacting patients' ability to complete four cycles of chemotherapy or undergo surgery.

References:

[1] Imfinzi granted Priority Review in the US for patients with muscle-invasive bladder cancer. Retrieved December 6, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-granted-priority-review-in-the-us-for-patients-with-muscle-invasive-bladder-cancer.html

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