▎WuXiEdited by Kant Content Team

AstraZeneca announced today at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) the results of a post-hoc exploratory subgroup analysis from the Phase 3 NIAGARA clinical trial. The analysis showed that its重磅 immunotherapy Imfinzi (durvalumab), as part of a perioperative treatment regimen combined with neoadjuvant chemotherapy, improved event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC), regardless of whether they achieved pathological complete response (pCR). The press release noted,NIAGARA is the first phase 3 trial to demonstrate a statistically significant and clinically meaningful improvement in both EFS and OS with a perioperative immunotherapy regimen in muscle-invasive bladder cancer, showing the potential of this combination to become the standard treatment for this indication.

In the NIAGARA trial, patients received four cycles of Imfinzi combined with neoadjuvant chemotherapy, followed by radical cystectomy and then eight cycles of Imfinzi monotherapy. Post-hoc analysis showed,InIn patients who achieved pCR, this treatment regimen reduced the risk of disease progression, recurrence, non-surgery, or death by 42% compared to neoadjuvant chemotherapy alone. In patients who did not achieve pCR, the risk was reduced by 23%.

In addition,In patients who achieved pCR, the combination of Imfinzi and neoadjuvant chemotherapy reduced the risk of death by 28%, and in patients who did not achieve pCR, the risk of death was reduced by 16%.

Compared with the active control group, the Imfinzi perioperative regimen also improved two secondary endpoints in the intent-to-treat (ITT) population – metastasis-free survival (MFS) and disease-specific survival (DSS). This regimen reduced the risk of distant metastasis or death by 33%, and the risk of death caused by bladder cancer by 31%.

Imfinzi was generally well-tolerated, with no new safety signals observed during the neoadjuvant and adjuvant treatment phases. Moreover, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known safety profile of the combination and did not impact patients' ability to complete surgery. Immune-mediated adverse events were consistent with the known safety profile of Imfinzi, manageable, and mostly low-grade.

Imfinzi is a humanized monoclonal antibody. By binding to PD-L1, it blocks the interaction between PD-L1 and PD-1 as well as CD80 proteins, thereby inhibiting the immune escape mechanism of tumors.For MIBC patients,The treatment regimen of Imfinzi in the perioperative setting in combination with neoadjuvant chemotherapy was granted Priority Review by the US FDA in December 2024. Based on the NIAGARA trial, regulatory submissions for this regimen are currently under review in the EU, Japan, and several other countries and regions.

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