Study 2 was a randomized (1:1), open-label, multicenter study comparing the Zevalin therapeutic regimen with rituximab. The trial was conducted in 130 patients with relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma (NHL); no patient had received prior rituximab. Patients had histologically confirmed NHL requiring therapy, a WHO PS 0-2, <25% bone marrow involvement by NHL, no prior bone marrow transplantation, and acceptable hematologic function. Sixty-four patients received the Zevalin therapeutic regimen, and 66 patients received rituximab given as an IV infusion at 375 mg per m² weekly times 4 doses. The primary efficacy endpoint of the study was ORR using the IWRC (see Table 8). The ORR was significantly higher for patients receiving the Zevalin therapeutic regimen (83% vs. 55%, p<0.001). Time-to-disease-progression was not significantly different between study arms..

Table 8. Summary of Efficacy Data¹

Study 3 was a single arm study of 30 patients of whom 27 had relapsed or refractory low-grade, follicular NHL and a platelet count 100,000 to 149,000/mm³. Patients with ≥25% lymphomatous marrow involvement, prior myeloablative therapy with stem cell support, prior external beam radiation to > 25% of active marrow or neutrophil count <1,500/mm³ were ineligible for Study 3 All patients received [0.3 mCi per kg (11.1 MBq per kg). Objective, durable clinical responses were observed [89% ORR (95% CI: 70-97%) with a median duration of response of 11.6 months (range: 1.0-42.4+ months)].

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