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Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)
Date:12/8/2008

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The most common adverse events seen were infusion related reactions, which were mostly mild to moderate in severity. The most common serious adverse events (Grade 3 or 4) were infections (25 percent in DR; 25 percent in BFR), including one case of progressive multifocal leukoencephalopathy (PML) in a patient with progressive disease. Early death (within eight weeks from start of treatment) occurred in four patients (7 percent) in the DR group and two patients (3 percent) in the BFR group. Tumor lysis syndrome was also reported following treatment with ofatumumab. Common adverse reactions (greater than or equal to 10%) were pyrexia, cough, diarrhea, rash, neutropenia, fatigue, pneumonia, anemia, dyspnea, nausea, and upper respiratory tract infection. No patient tested positive for antibodies to ofatumumab.(1)

"There is a great unmet medical need among patients with CLL that is refractory to conventional therapy. The clinical responses and the tolerability profile we are seeing with ofatumumab in this group of CLL patients are very encouraging," said lead investigator Professor Anders Osterborg, Department of Hematology, Karolinska Hospital, Stockholm, Sweden.

In a post hoc, subset analysis prior treatment with rituximab did not have a significant effect on ofatumumab treatment efficacy. Of those patients who had received prior rituximab-containing therapy 54 percent in the DR group and 44 percent in the BFR group responded to treatment with ofatumumab.(1)

"The positive results seen in this interim analysis reinforce the potential of ofatumumab in the treatment of CLL refractory to standard treatments," said Moncef Slaoui, Chairman Research and Development at GSK. "We are committed to the development of ofatumumab in both CLL and other disease settings to provide an additional treatment option to patients suffering from hematological malignancies."

"Ofatumumab has helped re
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SOURCE GlaxoSmithKline
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