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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 encouraging clinical data from investigator-sponsored studies of MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and FOLOTYN® (pralatrexate injection).
“At the ASH meeting there were several presentations on our drugs and we are especially excited about two,” said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Data from Marqibo’s Phase 2 study suggests the drug potentially could have utility in the treatment of Diffuse Large B-cell Lymphoma (DLBCL), in the front-line setting. DLBCL is a disease with a poor prognosis and better treatments are needed to improve outcomes for these patients. These data reinforce our excitement in Marqibo’s continuing development strategy, which currently includes the ongoing investigator-initiated Phase 3 Optimal>60 trial being conducted by the German High-Grade NHL Study Group in the same patient population. The second abstract provides data on the use of Folotyn as front-line therapy in patients with Peripheral T-cell Lymphoma (PTCL). These findings suggest that Folotyn may provide benefit to patients with early stage disease, a setting that we are currently exploring in a large Phase 3 study.”
Select ASH Presentation Summaries
Following are summaries of key presentations at ASH:
Abstract # 3033 - Long Term Results Of a Phase 2 Study Of Vincristine Sulfate Liposome Injection (Marqibo®) Substituted For Non-Liposomal Vincristine In CHOP With Or Without Rituximab For Patients With Untreated Aggressive Non-Hodgkin’s Lymphomas
This study evaluated 60 patients with untreated DLBCL in which Marqibo was substituted for Vincristine (VCR) in R-CHOP creating R-CHMP. The primary endpoint was overall response rate (ORR), and secondary endpoints were Progression free survival (PFS) and overall survival (OS). The overall response rate was 95% (57/60) and the complete response rate (CR) was 90% (54/60). Ten year PFS and OS were 64% and 87%, respectively. In patients greater than 60 years of age, overall response rate was 91%, 10 year PFS= 48%, and 10 year OS was 65%. The safety profile of R-CHMP was comparable to what has been reported in the literature for R-CHOP. Grade 3 peripheral neuropathy was 3%. The authors concluded that the R-CHMP “resulted in a high ORR and encouraging PFS and OS without apparent increased toxicity compared to historical experience with R-CHOP. In particular, elderly DLBCL patients with an unfavorable prognosis, based on age-adjusted International Prognostic Index (aaIPI) experienced remarkable PFS and OS.”