Spectrum Pharmaceuticals has reported results from a randomised study comparing Zevalin (ibritumomab tiuxetan) injection for intravenous use plus high-dose BEAM chemotherapy with BEAM chemotherapy alone.
The randomised study has evaluated the safety and efficacy of standard-dose Zevalin 14 days prior to ASCT, followed by high-dose BEAM chemotherapy (Z-BEAM) and ASCT in refractory / relapsed aggressive lymphoma. The comparator group received BEAM alone (Carmustine, Etoposide, Cytarabine, and Melphalan) six to one day prior to ASCT.
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In the study, 43 patients with CD20 positive, aggressive lymphoma were randomised to a treatment arm (Z-BEAM, n=22) or control arm (BEAM alone, n=21). Two-years after ASCT, for two-year progression-free survival (PFS) in all patients of 48% (95% confidence interval, 32%-64%): 59% after Z-BEAM and 37% after BEAM alone (p=0.20), 20 relapses had occurred.
Multivariate analysis identified advanced age, high-risk disease, positive positron emission tomography computed tomographypretransplant and BEAM alone as poor prognostic factors. Two-year overall survival rate was 91% for Z-BEAM vs 62% for BEAM Alone (p= 0.05).
The standard-dose ibritumomab tiuxetan combined with BEAM high-dose chemotherapy is safer and more effective than BEAM alone as a conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.
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Spectrum chairman and CEO Rajesh Shrotriya said that the company believes confirmatory results will lead to FDA approval and rapid adoption of Zevalin in this setting. "This study highlights a major advance for DLBCL and other patients with relapsed/refractory aggressive lymphomas since the PARMA study (1995) established ASCT as standard of care in this setting," he added.
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By GlobalDataThe company will expand the clinical development programme for Zevalin to include support for a larger study using Z-BEAM for ASCT. The current clinical programme will include a Phase III study in diffuse large B-cell lymphoma, and a trial to evaluate Zevalin in previously untreated follicular non-Hodgkin’s lymphoma patients.
