Boston Biomedical Discontinues Napabucasin Study

Boston Biomedical has announced the 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.

"Pancreatic cancer is an area of high unmet need and our hope was to develop a new therapeutic option for patients. We are disappointed with the results of this interim analysis and would like to express gratitude to the trial participants, their families, investigators and staff for their efforts and contributions to this study," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "Boston Biomedical and our parent company, Sumitomo Dainippon Pharma Co., Ltd., remain committed to CanStem303C, a phase 3 trial of napabucasin in metastatic colorectal cancer, and to oncology as a key priority for the organizations."

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.

Napabucasin is an orally-administered investigational agent that is bioactivated by NQO1, which generates reactive oxygen species (ROS) to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death.

Napabucasin is being investigated in CanStem303C, a phase 3 trial for metastatic colorectal cancer (NCT02753127). It is also being investigated in earlier phase trials in multiple solid malignancies.

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