BBI608: Phase Ib data

Data from 15 evaluable patients with advanced malignancies in the open-label, North American Phase Ib BBI608-201 trial showed that twice-daily 200, 400 or 500 mg BBI608 plus paclitaxel led to a disease control rate (DCR) of 67%. Of 5 patients with refractory gastric or gastroesophageal junction adenocarcinoma, 3 showed tumor regression and 2 who failed prior taxane therapy had stable disease (SD) for >5 months. BBI608 also led to tumor regression or SD of >4 months in 1 patient with platinum-resistant ovarian cancer, 2 melanoma patients, 1 bladder cancer patient and 1 patient with non-small cell lung cancer (NSCLC). The most common adverse events reported were grade 1/2 diarrhea, abdominal cramps, nausea and vomiting. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

In May, the company discontinued the Phase III CO.23 trial evaluating BBI608 plus best supportive care (BSC) to treat colorectal cancer after a futility analysis based on disease control rate (DCR) of the first 97 patients met the protocol-defined criteria for stopping the trial (see BioCentury, June 2). At the time, Dainippon said it would continue its other clinical trials evaluating BBI608 in various combination regimens, including a Phase III trial in combination with paclitaxel to treat gastric cancer and a Phase II trial in combination with cetuximab, panitumumab or capecitabine to treat colorectal cancer. The company gained BBI608 through its 2012 acquisition of Boston Biomedical Inc. (see BioCentury, April 30, 2012). ...