Spectrum Pharmaceuticals Inc.(SPPI), a biotechnology company with fully integrated commercial and drug development operations and a primary focus in hematology and oncology, today announced positive results from the BELIEF trial, a pivotal, single-arm study of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma or R/R PTCL after failure of =1 prior systemic therapies. Belinostat (PXD 101) is a pan-HDAC inhibitor being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic agents for the treatment of various hematological and solid cancers.
The BELIEF study enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy; diagnosis was confirmed by Central Pathology Review. The primary study end point was the overall response rate or ORR as assessed by an Independent Review Committee.
Single-agent belinostat was shown to induce complete and partial responses even in poor prognosis R/R PTCL subtypes. Belinostat was well-tolerated, requiring minimal dose reductions or dose delays leading to the successful delivery of high dose intensity treatment to heavily pretreated patients.
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