Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity FcγRIIIa Patients with Previously Treated Follicular Lymphoma

Kristen N Ganjoo; Sven de Vos; Brad L Pohlman; Ian W Flinn; Andres Forero-Torres; Nathan H Enas; Damien M Cronier; Nam H Dang; Kenneth A Foon; Susan P Carpenter; Christopher A Slapak; Brian K Link; Mitchell R Smith; Markus Y Mapara; James E Wooldridge

doi:10.3109/10428194.2014.911859

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Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity FcγRIIIa Patients with Previously Treated Follicular Lymphoma

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Peer reviewed

Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity FcγRIIIa Patients with Previously Treated Follicular Lymphoma

Kristen N Ganjoo, Sven de Vos, Brad L Pohlman, Ian W Flinn, Andres Forero-Torres, Nathan H Enas, Damien M Cronier, Nam H Dang, Kenneth A Foon, Susan P Carpenter, …

Leukemia & lymphoma, Vol.56(1), pp.42-48

01/02/2015

DOI: 10.3109/10428194.2014.911859

PMID: 24717109

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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 FcγRIIIa 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 FcγRIIIa genotypes. ClinTrials registry number: NCT00354926.

Follicular lymphoma

ocaratuzumab

FcγRIIIa

Details

Title: Subtitle: Phase 1/2 Study of Ocaratuzumab, an Fc-Engineered Humanized Anti-CD20 Monoclonal Antibody, in Low-Affinity FcγRIIIa Patients with Previously Treated Follicular Lymphoma
Creators: Kristen N Ganjoo - Stanford Cancer Center
Sven de Vos - David Geffen School of Medicine at University of California Los Angeles
Brad L Pohlman - Cleveland Clinic - Taussig Cancer Institute
Ian W Flinn - Sarah Cannon Research Institute
Andres Forero-Torres - University of Alabama at Birmingham
Nathan H Enas - Eli Lilly and Company
Damien M Cronier - Eli Lilly and Company
Nam H Dang - Division of Hematology/Oncology, University of Florida
Kenneth A Foon - Celgene Corporation
Susan P Carpenter - Applied Molecular Evolution
Christopher A Slapak - Eli Lilly and Company
Brian K Link - Holden Comprehensive Cancer Center at University of Iowa
Mitchell R Smith - Cleveland Clinic - Taussig Cancer Institute
Markus Y Mapara - Columbia University Medical Center
James E Wooldridge - Eli Lilly and Company
Resource Type: Journal article
Publication Details: Leukemia & lymphoma, Vol.56(1), pp.42-48
Publisher: Taylor & Francis
DOI: 10.3109/10428194.2014.911859
PMID: 24717109
ISSN: 1042-8194
eISSN: 1029-2403
Language: English
Date published: 01/02/2015
Academic Unit: Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
Record Identifier: 9984094339902771

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