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.
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.
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.
The 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.