AstraZeneca Received NMPA Approval for Imfinzi + CT to Treat Patients with Locally Advanced/metastatic Biliary Tract Cancer
Shots:
- 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 NEJM. Imfinzi (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 is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
