Why did the phase III NuTide:121 trial fail to show improved overall survival with NUC-1031?

Label:chem

Topic
The NuTide:121 trial was designed to compare the efficacy of NUC-1031 plus cisplatin versus gemcitabine plus cisplatin in patients with advanced biliary tract cancer. The trial was terminated early due to futility in overall survival during interim analysis.
Answer
The trial failed to show improved overall survival with NUC-1031 due to several factors. Firstly, there was a higher incidence of liver-related adverse events in the NUC-1031 arm, including elevated aminotransferase, bilirubin, and drug-induced liver injury (DILI). These toxicities likely led to reduced treatment exposure, with a median of 4 cycles in the NUC-1031 arm compared to 6 cycles in the control arm. Additionally, the objective response rate (ORR) was lower than expected, and the difference was not statistically significant. The study suggests that pre-existing liver impairment in aBTC patients may have exacerbated NUC-1031-induced liver injury.
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