Phase III study of napabucasin + nab-paclitaxel + gemcitabine for pancreatic cancer

Boston Biomedical/Sumitomo Dainippon announced that the Phase III CanStem111P study evaluating the safety and efficacy of investigational agent napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma will be discontinued due to futility

This decision is based on a recommendation by the independent Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis of futility at 50 percent of the total planned events. No new safety concerns were raised by the DSMB. Boston Biomedical intends to work with study investigators to complete a full evaluation of the CanStem111P trial results. The data and analyses of this study will be provided to regulatory authorities and will be presented and published for the oncology community.