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AstraZeneca Received NMPA Approval for Imfinzi + CT to Treat Patients with Locally Advanced/metastatic Biliary Tract Cancer

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AstraZeneca Received NMPA Approval for Imfinzi + CT to Treat Patients with Locally Advanced/metastatic Biliary Tract Cancer

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  • The NMPA approval was based on P-III (TOPAZ-1) study conducted around 105 centres & 17 countries evaluating Imfinzi + CT (gemcitabine + cisplatin) vs PBO + CT as a 1L treatment in patients (n=685) with unresectable advanced/metastatic BTC. The OS was considered for 1EP & PFS, ORR & safety as 2EP
  • The interim analysis of the study found that Imfinzi+CT decreased the risk of mortality by 20% vs CT alone, the mOS was 12.8 vs 11.5mos. Furthermore, prespecified exploratory analysis showed decreased risk of mortality by 22% vs CT among Chinese patients which was similar to the overall outcomes of the global trial population
  • The study result was published in NEJMImfinzi (durvalumab) binds to the PD-L1 protein and prevents it from interacting with the PD-1 and CD80 proteins.

Ref: AstraZeneca Image: AstraZeneca

Related News:- AstraZeneca Reports the Results for Imfinzi in P-III Trial for the Treatment of Hepatocellular Carcinoma

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Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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