Genmab/GlaxoSmithKline: first approval for Arzerra

The FDA has granted accelerated approval for Arzerra (ofatumumab; Genmab/GlaxoSmithKline) following a positive recommendation by its Oncologic Drugs Advisory Committee. The decision was based on a pivotal study involving 225 chronic lymphocytic leukemia (CLL) patients who were refractory to both fludarabine and Campath (alemtuzumab; Genzyme). In this study, the objective response rate for patients who received Arzerra was 42%, and the median response duration was 6.5 months.

Arzerra is a high-affinity fully human monoclonal antibody that targets the CD20 antigen, a protein expressed on the surface of normal and malignant B-cells. In addition to the Phase III study involving refractory CLL patients, Arzerra is currently in Phase III trials for the first-line treatment of CLL in combination with chlorambucil. Arzerra failed to reach the primary end point in a recent Phase III trial for refractory non-Hodgkin's lymphoma (NHL).

CLL is an incurable disease characterized by an accumulation of mature B-lymphocytes. Datamonitor forecasts that the incidence of CLL in the seven major pharmaceutical markets for 2009 will be over 25,000. However, according to this firm's primary research, the CLL patient population treated with both fludarabine and Campath is relatively small. For these patients there is a lack of effective treatment options, and uptake of Arzerra is likely to be high given the level of unmet need. More importantly, Genmab and GlaxoSmithKline have gained their first foothold in the monoclonal antibody market. By targeting a niche population of patients, the companies have gained US approval and avoided immediately entering into direct competition with Rituxan (rituximab; Biogen Idec/Genentech/Roche/Chugai/Zenyaku Kogyo).

In order to realize a more significant return on investment, Genmab and GlaxoSmithKline will need Arzerra to achieve further indication expansions. This will inevitably lead to competition with Rituxan, which is also a CD20-targeted monoclonal antibody. Rituxan is well established as the treatment of choice for B-cell malignancies like CLL and NHL, and will provide fierce competition for Arzerra in these indications. The potential of Arzerra in these indications remains unclear, particularly in light of the recent disappointing results from the Phase III refractory NHL trial.

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