BAY 86-9766: Phase II data

An open-label, Asian Phase II trial in 65 evaluable patients with unresectable HCC showed that twice-daily 50 mg oral BAY 86-9766 plus sorafenib as first-line treatment produced a DCR of 43%, with 3 confirmed partial responses and 25 cases of stable disease for >=10 weeks. Median TTP was 4.1 months and OS data are not yet mature. The most common adverse events were rash, diarrhea, elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, vomiting, nausea and anorexia. There were 4 deaths due to hepatic failure, sepsis/hepatic encephalopathy, tumor lysis and syndrome and unknown cause, respectively. Dose modifications due to adverse events were necessary in almost all patients. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...