Belinostat: Final Phase II data

Final data from the open-label, international, pivotal Phase II BELIEF (PXD101-CLN-19) trial in 129 patients with relapsed or refractory PTCL showed that once-daily IV belinostat led to an ORR of 26%, including a 10% complete response rate and a 16% partial response rate. Median duration of response was 8.3 months and the longest duration of response was 29.4 months. The trial enrolled patients who failed >=1 systemic therapy to receive once-daily 1,000 mg/m 2 IV belinostat on days 1-5 of a 21-day cycle. The partners have an SPA from FDA for the trial. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...