|Demographic||Cohort 1 + Cohort 2|
|Evaulable Patients (≥1 cycle)||11|
In January 2018, NuCana announced interim results from the multi-center ABC-08 study. A complete response was achieved in one patient, partial responses in three patients, and stable disease in another patient, resulting in an objective response rate of 50% and a disease control rate of 63% on an intent-to-treat basis. This is an improved response rate compared to that seen with the current standard treatment for inoperable biliary tract cancer. The combination of Acelarin and cisplatin was well-tolerated with no unexpected adverse events and no dose-limiting toxicities. The optimal dose combination was determined to be Acelarin at 625 mg/m2 with cisplatin at 25 mg/m2.
In October 2018, NuCana announced additional interim results from this study. 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 tumour volume as well as further tumour shrinkage over time. Fourteen patients with advanced/metastatic biliary tract cancer received Acelarin (625 mg/m2 or 725 mg/m2) and cisplatin (25 mg/m2) 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 (defined as those patients who received at least one cycle of therapy), an Objective Response Rate of 64% was achieved.
Based on these encouraging interim results, we plan to initiate a Phase III study of Acelarin and cisplatin as a front-line treatment of patients with locally advanced or metastatic biliary tract cancers in 2018.
|Acelarin + cisplatin
625 mg/m2 or 725 mg/m2
+ 25 mg/m2
|gemcitabine + cisplatin
+ 25 mg/m2
|Complete Response||7% (1/14)||0.6% (1/161)|
|Partial Response||43% (6/14)||25.5% (41/161)|
|Objective Response Rate||50% (7/14)||26.1% (42/161)|