RECRUITMENT COMPLETED IN ARZERRA™ (OFATUMUMAB) PIVOTAL CLL STUDY
- Category: Antibodies
- Published on Thursday, 09 July 2009 03:00
- Hits: 1385
Genmab announced it has completed recruitment of patients in the pivotal study of Arzerra™ (ofatumumab) in the treatment of refractory chronic lymphocytic leukemia (CLL)
Copenhagen, Denmark | July 9, 2009 | Genmab A/S (OMX: GEN) announced today it has completed recruitment of patients in the pivotal study of Arzerra™ (ofatumumab) in the treatment of refractory chronic lymphocytic leukemia (CLL). A total of 220 patients have been enrolled in the study including 100 patients refractory to fludarabine and alemtuzumab, 100 patients who are refractory to fludarabine and considered inappropriate candidates for alemtuzumab and 20 patients who did not qualify for either category.
Based on positive results from an interim analysis in this study, Genmab and GlaxoSmithKline submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in January and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in February.
About the study
The study includes patients with CLL refractory to both fludarabine and alemtuzumab, and patients who are refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor masses in their lymph nodes. The study design calls for patients to receive eight weekly infusions of ofatumumab, followed by four monthly infusions. Patients receive 300 mg of ofatumumab at the first infusion and 2,000 mg of ofatumumab at each subsequent infusion. Disease status is assessed every four weeks until week 28 and then every three months until disease progression or month 24.
The primary endpoint of the study is objective response over a 24 week period from start of treatment as assessed according to the National Cancer Institute Working Group guidelines by an Independent endpoint Review Committee (IRC). The secondary endpoints include duration of response, progression free survival, time to next CLL therapy, overall survival and adverse events.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.