Spectrum Pharma Reports Positive Data from BELIEF Trial at ASCO

Spectrum Pharmaceuticals 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 (R/R PTCL) after failure of ≥1 prior systemic therapies. Data presented at an oral session at ASCO demonstrated the clinical activity of belinostat, a novel pan-histone deacetylase inhibitor, in treating patients (N=129) with R/R PTCL with: * Overall Response Rate (ORR) of 26% in heavily pretreated patients * Median Duration of Response (DoR) of 13.6 months by International Working Group (IWG) criteria * Anti-tumor activity demonstrated in poor prognosis PTCL subtypes including angioimmunoblastic T-cell lymphoma (AITL) with a ORR of 46%, patients with poor marrow reserves and low platelet counts (<100,000 per mcL), and patients with previous autologous and allogeneic stem cell transplants * Well tolerated with an acceptable safety profile and >98% dose intensity that could potentially allow for novel combination chemotherapies “These data are very encouraging and demonstrate the potential clinical activity and safety of belinostat as a single agent in the treatment of patients with relapsed or refractory PTCL,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Despite the recent approvals of new treatments for R/R PTCL, there remains an unmet medical need with approximately 70% of patients failing current therapies, so clearly these patients need alternative effective treatment options. We are excited that Spectrum is on track to file an NDA for belinostat for this indication in 2013.” “In this study, Belinostat demonstrated important clinical efficacy in poor prognosis relapsed and refractory PTCL patients,” said Dr. Owen A. O'Connor, Professor of Medical and Experimental Therapeutics and Director of the Center for Lymphoid Malignancies at the Columbia University Medical Center College of Physicians and Surgeons, one of the lead investigators in the belinostat study. “Its safety profile and tolerability in patients with poor marrow reserve makes it an ideal candidate for the development of new combination treatment paradigms for PTCL.” 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. Patients received belinostat at 1,000 mg/m^2 as a 30 minute intravenous infusion on days 1 thru 5 every 21 days. The primary study end point was the overall response rate (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, e.g., angioimmunoblastic T-cell lymphoma (AITL) and ALK (-) anaplastic large cell lymphoma. Overall, 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.