(RTTNews) - AstraZeneca PLC (AZN.L, AZN) announced Monday positive high-level results from the TOPAZ-1 Phase III trial that showed Imfinzi (durvalumab) plus chemotherapy significantly improved overall survival in 1st-line advanced biliary tract cancer or BTC patients.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder.
At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in overall survival or OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone.
The combination also demonstrated an improvement in progression-free survival or PFS and overall response rate, key secondary endpoints.
It is the first immunotherapy combination to demonstrate superior clinical outcomes over standard of care in a global, randomised trial in this setting. The company noted that Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.
The data will be presented at a forthcoming medical meeting and shared with health authorities.
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