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AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

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  • The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas
  • Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063) with median MFS & DSS not reached, reducing distant metastases/death risk by 33% & bladder cancer death risk by 31%, where 37.3% vs 27.5% pts achieved pCR
  • In pCR pts (n=345; EFS: 92.1% vs 85.8% & OS: 95.5% vs 91.1%) & non-pCR pts (n=718; EFS: 53.3% vs 49.5% & OS: 74.1% vs 68.9%), the study showed reduced risk in disease worsening, recurrence, surgery failure, or death by 42% & 23%, plus reduced death risk by 28% & 16%, respectively, as of Apr 29, 2024

Ref: AstraZeneca  | Image: AstraZeneca

Related News:- AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

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