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
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