AstraZeneca Announces First Perioperative Immunotherapy to Significantly Extend Overall Survival in Muscle-Invasive Bladder Cancer: Positive Phase III NIAGARA Trial Results

Jun 26, 2024 07:22 CST Updated 07:22

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXiEdited by Kant Content Team

Today, AstraZeneca announced positive results from the Phase 3 clinical trial NIAGARA. The analysis showed that, compared to neoadjuvant chemotherapy alone, the combination of its重磅 immunotherapy Imfinzi with chemotherapy significantly prolonged overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC) both statistically and clinically. According to the press release,This is the first immunotherapy regimen that can be used before surgery and after surgery to extend the survival period of bladder cancer patients.

NIAGARA is a randomized, open-label, multi-center, global Phase III clinical trial evaluating the efficacy of Imfinzi in treating MIBC patients before and after radical cystectomy.In the trial, 1063 patients were randomly assigned to receive either Imfinzi combined with chemotherapy or chemotherapy alone before bladder removal surgery, followed by Imfinzi or no further treatment post-surgery.

The analysis shows,Imfinzi in combination with chemotherapy showed statistically significant and clinically meaningful improvements in both primary endpoints of event-free survival (EFS) and overall survival compared to neoadjuvant chemotherapy alone in patients with MIBC.Imfinzi was generally well-tolerated, with no new safety issues observed in either the neoadjuvant or adjuvant settings. The safety profile of Imfinzi in combination with neoadjuvant chemotherapy was consistent with the known profiles of each drug.

MIBCRefers toTumor invades the bladder muscular wallBut did not occurDistant metastasis of bladder cancer accounts for approximatelyOne Quarter。InMIBCIn the treatment of , currently about11.7Ten ThousandPatients received standard treatment.Standard treatment includes neoadjuvant chemotherapy and radical cystectomy.（cystectomy）。However, even after bladder removal, patients still face a high recurrence rate and poor prognosis.

Imfinzi is a humanized monoclonal antibody that binds to the PD-L1 protein and blocks the interaction between PD-L1 and PD-1 as well as CD80 proteins., thereby countering the tumor's immune escape strategy, lifting the suppression on immune responses, and enhancing the immune system's ability to kill cancer cells.

▲To learn more about the application of cutting-edge technologies in the biopharmaceuticals industry, please long-press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.

References:

[1] Imfinzi demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival for muscle-invasive bladder cancer in NIAGARA Phase III trial. Retrieved June 25, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-improved-efs-and-os-in-bladder-cancer.html

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. For guidance on obtaining a treatment plan, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media circles, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.

Share，PointLike，In View, Focusing on Global Biomedical Health Innovation