▎WuXiEdited by Kant Content Team
Today, AstraZeneca announced the latest exploratory analysis results of the Phase 3 clinical trial TOPAZ-1. The data shows that itsImfinzi, a key immunotherapy, combined with standard chemotherapy, provided clinically meaningful long-term overall survival (OS) benefits for patients with advanced biliary tract cancer (BTC) at the 3-year mark.
At a median follow-up time of 41.3 months, the analysis results showedImfinzi plus chemotherapy group reduced the risk of death by 26% compared with chemotherapy alone (HR=0.74; 95% CI, 0.63-0.87).The median overall survival in the Imfinzi plus chemotherapy group was 12.9 months, compared with 11.3 months in the chemotherapy-alone group.Patients treated with the Imfinzi combination therapy had more than double the survival rate at three years compared to the chemotherapy-alone group (14.6% vs. 6.9%).
The TOPAZ-1 trial met its primary endpoint of overall survival in a pre-specified interim analysis in October 2021, showing a 20% reduction in the risk of death with the combination therapy compared to chemotherapy alone (HR=0.80; 95% CI, 0.66-0.97; two-sided p=0.021, statistical significance threshold of 0.03).
▲3Latest Exploratory Analysis Data from Phase Clinical Trial TOPAZ-1 (Image Source: Reference [1])
ImfinziAddTolerance to ChemotherapyContinued to be favorable, and no new safety signals were observed with the extension of follow-up time.15.4% of patients receiving Imfinzi plus chemotherapy experienced serious treatment-related adverse events, compared with 17.3% in the chemotherapy-alone group.
Imfinzi is a humanized monoclonal antibody that binds to the PD-L1 protein and blocks the interaction between PD-L1 and PD-1 as well as CD80 proteins., thereby countering the tumor's immune escape strategy, lifting the suppression on immune responses, and enhancing the immune system's ability to kill cancer cells.
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Reference MaterialsMaterial:
[1] mfinzi plus chemotherapy doubled overall survival rate at three years for patients with advanced biliary tract cancer in TOPAZ-1 Phase III trial. Retrieved April 16, 2024, from https://od-prod-origin-astrazeneca-corporate.digital-astrazeneca.com/media-centre/press-releases/2024/imfinzi-plus-chemotherapy-doubled-overall-survival-rate-at-three-years-for-patients-with-advanced-biliary-tract-cancer-in-topaz-1-phase-iii-trial.htmlDisclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article. This article is not a recommendation for treatment plans. If you need guidance on treatment options, please visit a regular hospital.Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the "WuXi AppTec" WeChat Official Account to obtain reprint guidelines.
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