What is NUC-1031 and its role in the treatment of advanced biliary tract cancer (aBTC)?

Label:chem

Topic
NUC-1031 is a phosphoramidate transformation of gemcitabine, a nucleoside analog used in cancer chemotherapy. It was developed to potentially improve the efficacy and safety profile of gemcitabine. The study discusses its evaluation in the phase III NuTide:121 trial for the treatment of advanced biliary tract cancer (aBTC).
Answer
NUC-1031 showed early promise in phase I trials with favorable safety and disease control in heavily pre-treated patients with solid tumors. However, in the phase III NuTide:121 trial, NUC-1031 combined with cisplatin did not improve overall survival compared to the standard gemcitabine/cisplatin regimen. It demonstrated a higher incidence of liver-related adverse events, leading to reduced treatment exposure and inferior overall survival. The study highlights the importance of thorough phase II evaluation before proceeding to phase III trials.
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