TopoTarget A/S Announces Results of Belinostat BELIEF Trial

TopoTarget A/S announced that the final top-line data confirm that the primary endpoint was met for the belinostat pivotal trial for patients with relapsed or refractoryperipheral T-cell lymphoma (PTCL) with an encouraging objective response rate. The data show an objective response rate (ORR) in the efficacy analysis set which is above the protocol criterion for a positive outcome of the trial. Belinostat thus has an ORR that is on par with the accelerated approved drugs Folotyn and Istodax. A Special Protocol Assessment agreement with the United States Food and Drug Administration (FDA) required the CLN-19 BELIEF trial to reach an ORR of at least 20%. The FDA has granted belinostat Orphan Drug and Fast Track designation for the treatment of PTCL. All patients who received at least one dose of belinostat and had a confirmed PTCL diagnosis by the central pathology review were included in the efficacy analysis set. The responses have been confirmed by central independent radiology review.