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Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity Fc?RIIIa Patients with Previously Treated Follicular Lymphoma. Leukemia & lymphoma Ganjoo, K. N., de Vos, S., Pohlman, B. L., Flinn, I. W., Forero-Torres, A., Enas, N. H., Cronier, D. M., Dang, N. H., Foon, K. A., Carpenter, S. P., Slapak, C. A., Link, B. K., Smith, M. R., Mapara, M. Y., Wooldridge, J. E. 2015; 56 (1): 42-48

Abstract

Abstract This phase 2 study assessed the safety and efficacy of ocaratuzumab, a humanized anti-CD20 monoclonal antibody. Fifty patients with previously treated follicular lymphoma (FL) and a low-affinity genotype of Fc?RIIIa received ocaratuzumab 375 mg/m(2) weekly for 4 weeks. Grade 3/4/5 adverse events (AEs) were reported in 11/1/1 patients, respectively. Serious AEs were reported by 11/50 patients, and three discontinued due to AEs. One patient died from aspiration pneumonia due to possibly drug-related nausea and vomiting. Investigator-assessed response rate was 30% (15/50), including four complete responses (CR), three CR unconfirmed (CRu) and eight partial responses (PR). Investigator-assessed median Progression-free survivial (PFS) was 38.3 weeks. Ocaratuzumab's pharmacokinetic profile was similar to that reported for rituximab. Lymphocyte subset analysis showed significant, selective reduction of B-cells during and after ocaratuzumab treatment. Ocaratuzumab at this dose and schedule is active and well tolerated in patients with previously treated FL with low affinity Fc?RIIIa genotypes. ClinTrials registry number: NCT00354926.

View details for DOI 10.3109/10428194.2014.911859

View details for PubMedID 24717109