AstraZeneca Reports Results of Imfinzi in P-III TOPAZ-1 Trial as 1L Treatment for Advanced Biliary Tract Cancer

 AstraZeneca Reports Results of Imfinzi in P-III TOPAZ-1 Trial as 1L Treatment for Advanced Biliary Tract Cancer

Shots:

  • The P-III TOPAZ-1 trial evaluates Imfinzi + CT vs PBO + CT in 685 patients with unresectable advanced or metastatic BTC at 145 centers across 17 countries including the US, EU, South America & several countries in Asia
  • In a predefined interim analysis, IDMC has concluded that a trial met its 1EPs i.e., improvement in OS & also showed an improvement in PFS & ORR in 2EPs. The combination was well tolerated & had a similar safety profile
  • Imfinzi is also approved in the US, EU, Japan, China & multiple other countries globally for ES-SCLC based on the P-III CASPIAN trial. The therapy is being evaluated as a monothx. & in combinations with other anti-cancer treatments for multiple cancers

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