Shots:
- The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions
- Approval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery
- Interim analysis showed a 32% reduction in disease progression, recurrence, not undergoing surgery or death risk (mEFS: not reached vs 46.1mos.); 67.8% vs 59.8% were event free at 2yrs. Imfinzi also reduced death risk by 25% (mOS not reached for both arms), with 82.2% vs 75.2% pts alive at 2yrs.; data was presented at ESMO 2024 & published in The NEJM
Ref: AstraZeneca | Image: AstraZeneca| Press Release
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