BBI608: Phase I/II data

The open-label, North American Phase I/II BBI608-101 trial showed that a new undisclosed higher strength formulation of BBI608 given twice daily in patients with ovarian or anal squamous cancer (n=7) led to 2 cases of stable disease. In colorectal cancer patients (n=8), the higher strength formulation of BBI608 led to median progression-free survival (PFS) of 17 weeks and a median overall survival (OS) of 40 weeks. The disease control rate (DCR) was 67% in 6 evaluable colorectal cancer patients. The trial enrolled 24 patients with advanced solid tumors to receive 500 mg of the original BBI608 formulation on day 1 and 500 mg of the new formulation on days 4 and 8, followed by 500 mg of the new formulation twice daily until disease progression or toxicity. Adverse events included diarrhea, abdominal pain, nausea, vomiting, anorexia and fatigue. 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 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). ...