First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial.
Authors
Hagenbeek, AntonGadeberg, Ole
Johnson, Peter W
Pedersen, Lars Møller
Walewski, Jan
Hellmann, Andrzej
Link, Brian K
Robak, Tadeusz
Wojtukiewicz, Marek
Pfreundschuh, Michael
Kneba, Michael
Engert, Andreas
Sonneveld, Pieter
Flensburg, Mimi
Petersen, Jørgen
Losic, Nedjad
Radford, John A
Affiliation
University Medical Center Utrecht, Department of Hematology, Utrecht, The Netherlands. a.hagenbeek@umcutrecht.nlIssue Date
2008-06-15
Metadata
Show full item recordAbstract
Ofatumumab is a unique monoclonal antibody that targets a distinct small loop epitope on the CD20 molecule. Preclinical data show that ofatumumab is active against B-cell lymphoma/chronic lymphocytic leukemia cells with low CD20-antigen density and high expression of complement inhibitory molecules. In a phase 1/2 trial evaluating safety and efficacy of ofatumumab in relapsed or refractory follicular non-Hodgkin lymphoma (FL) grade 1 or 2, 4 dose groups of 10 patients received 4 weekly infusions of 300, 500, 700, or 1000 mg. Patients had a median of 2 prior FL therapies and 13% had elevated lactate dehydrogenase. No safety concerns or maximum tolerated dose was identified. A total of 274 adverse events were reported; 190 were judged related to ofatumumab, most occurring on the first infusion day with Common Terminology Criteria grade 1 or 2. Eight related events were grade 3. Treatment caused immediate and profound B-cell depletion, and 65% of patients reverted to negative BCL2 status. Clinical response rates ranged from 20% to 63%. Median time to progression for all patients/responders was 8.8/32.6 months, and median duration of response was 29.9 months at a median/maximum follow-up of 9.2/38.6 months. Ofatumumab is currently being evaluated in patients with rituximab-refractory FL. This trial was registered at www.clinicaltrials.gov as #NCT00092274.Citation
First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. 2008, 111 (12):5486-95 BloodJournal
BloodDOI
10.1182/blood-2007-10-117671PubMed ID
18390837Type
ArticleLanguage
enISSN
1528-0020ae974a485f413a2113503eed53cd6c53
10.1182/blood-2007-10-117671
Scopus Count
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