ndomized (1:1), open-label, multicenter study comparing the Zeva lin 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 Zeva lin therapeutic regimen, and 66 patients received rituximab given as an IV infusion at 375 mg per m2 weekly times 4 doses. The main efficacy outcome measure of the study was ORR using the IWRC. The ORR was significantly higher for patients receiving the Zeva lin therapeutic regimen (83% vs. 55%, p<0.001). Time-to-disease-progression was not significantly different between study arms. Table 9 summarizes efficacy data from Study 2.
Table 9. Summary of Efficacy Data* *
IWRC: International Workshop Response Criteria
CRu and CR: Unconfirmed and confirm complete response
Estimated with observed range
Duration of response: interval from the onset of response to disease progression
“+” indicates an ongoing response
Time to Disease Progression: interval from the first infusion to disease progression
Study 1 Study 2
Zeva lin
therapeutic regimen
N = 54 Zeva lin
therapeutic regimen
N = 64 Rituximab
N = 66
Overall Response Rate (%) 74 83 55
Complete Response Rate† (%) 15 38 18
Median DR
(Months)
[Range¶] 6.4
[0.5-49.9+] 14.3
[1.8-47.6+] 11.5
[1.2-49.7+]
Median TTP‡,#(Months)
[Range¶] 6.8
[1.1-50.9+] 12.1
[2.1-49.0+] 10.1
[0.7-51.3+]
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 Y-90 Zeva lin [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)].
14.2 Follicular, B-Cell NHL Upon Completion of First-Line Chemotherapy
Study 4 was a multi-center, randomized, open-label study conducted in patients with follicular NHL with a partial (PR) or complete response (CR/CRu) upon completion of first-line chemotherapy. Randomization was stratified by center and response to first-line therapy (CR or PR). Key eligibility criteria were <25% bone marrow involvement, no prior external beam radiation or myeloablative therapy, and recovery of platelets to normal levels. Patients were randomized to receive Zeva lin (n=208) or no further therapy (n=206). Y-90 Zeva lin was administered at least 6 weeks but no more than 12 weeks following the last dose of chemotherapy. The main efficacy outcome measure was progression-free survival (PFS) assessed by study investigators using the International Workshop to Standardize Response Criteria for non-Hodgkin’s Lymphoma (1999).
Among the 414 patients, 49% were male, 99% were Caucasian, 12% were ≥65 years old, 83% had a WHO performance status of 0, and 65% had Stage IV disease. Thirty-nine (9. |
