NuCana reports additional data on NUC-1031 in advanced biliary tract cancer
NuCana announced combined results from cohorts one and two of the ABC-08 study at the European Society for Medical Oncology Congress 2018 in Munich, Germany. In this Phase Ib multi-center, open-label study in front-line treatment of patients with advanced biliary tract cancer, Acelarin combined with cisplatin was observed to continue to achieve approximately a doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin. In addition, results showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time. Fourteen patients with advanced/metastatic biliary tract cancer received Acelarin and cisplatin on days one and eight of a three-week cycle. In the intent-to-treat group of patients, a Complete Radiological Response was achieved in one patient and a Partial Response in six patients, resulting in an Objective Response Rate of 50%. In the eleven Efficacy Evaluable patients, an Objective Response Rate of 64% was achieved. Additionally, the combination of Acelarin and cisplatin was well-tolerated over multiple cycles with no unexpected adverse events, no dose-limiting toxicities, no discontinuations due to Acelarin-associated toxicity and no Grade 4 adverse events. Based on these data from the ABC-08 study and discussions with the U.S. Food and Drug Administration, NuCana anticipates initiating a global randomized Phase III clinical study comparing Acelarin and cisplatin with gemcitabine and cisplatin in patients with front-line advanced biliary tract cancer.