Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced safety findings from the pivotal, registrational Phase 2 BELIEF trial of belinostat, a pan-histone deacetylase (HDAC) inhibitor. As featured in an oral presentation at the T-Cell Lymphoma Forum held in San Francisco, January 24-26, the BELIEF trial safety evaluation showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma (R/R PTCL), including patients who have received a previous allogeneic or autologous stem cell transplant.
The BELIEF trial is evaluating the efficacy and safety of intravenous belinostat for the treatment of patients with R/R PTCL. As announced in December 2012, the BELIEF trial surpassed an objective response rate (ORR) of at least 20% in these patients, the study’s primary efficacy endpoint as established under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
“We are pleased that the T-Cell Lymphoma Forum, one of the preeminent conferences for innovation in the treatment of blood cancers, highlighted the BELIEF study comprehensive safety profile,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Belinostat showed acceptable safety findings in the BELIEF trial which was designed to enroll relapsed or refractory PTCL patients; including those who received a previous stem cell transplant; with a platelet count greater than or equal to 50,000. Many of these refractory patients with low platelet counts were not eligible for treatment on trials with alternative agents. The BELIEF safety profile, as well as ongoing studies of belinostat in combination with cytotoxic regimens, may provide support to seek approval for indications in both monotherapy and combination therapy with belinostat for patients with PTCL. We look forward to progress of the program, including an anticipated NDA filing by mid-2013.”