Belinostat: Additional Phase II data

Topotarget reported additional data from the open-label, international, pivotal Phase II BELIEF (PXD101-CLN-19) trial in 129 patients with relapsed or refractory PTCL showing that once-daily IV belinostat led to an ORR that is "on par" with that of PTCL drugs Folotyn pralatrexate and Istodax romidepsin. Last September, top-line data from BELIEF showed that belinostat met the primary endpoint of an ORR of >=20% (see BioCentury, Sept. 24, 2012). According to their U.S. labels, Folotyn led to an ORR of 27% in a study in 109 evaluable PTCL patients, while Istodax produced an ORR of 25% in a study in 130 PTCL patients. BELIEF 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. Final data have been submitted for presentation at the American Society of Clinical Oncology meeting in Chicago this year. ...