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

Data from a pivotal trial suggests that ofatumumab has activity in heavily pre-treated patients who have failed standard treatments

PHILADELPHIA, Dec. 8 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today positive results from a pivotal trial pre-planned interim analysis of Arzerra(TM) (ofatumumab) in the treatment of refractory chronic lymphocytic leukemia (CLL). The results demonstrate the potential of ofatumumab for heavily pre-treated patients with CLL who do not respond to, or for whom currently available treatment options are not appropriate.(1) This research is being presented at the 50th Annual Meeting of the American Society of Hematology, 6-9 December, 2008. Ofatumumab is an investigational drug that has not been approved for any indication in any market at this time.

The analysis included 138 patients with CLL who showed limited or no response (refractory) to both fludarabine and alemtuzumab treatment (double refractory; DR), and patients who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor masses in their lymph nodes (bulky fludarabine refractory; BFR).

The primary endpoint of the study was assessment of objective response.* The overall objective response rate seen in these patient groups treated with ofatumumab monotherapy was 58 percent for the DR group (n=59) and 47 percent for the BFR group (n=79); all responding patients had a partial remission (PR**) except for one patient with a complete remission (CR***).(1) Median overall survival was 13.7 months for the DR group and 15.4 months for the BFR group;(1) response to ofatumumab treatment significantly correlated with longer patient survival. The median length of time that a patient lived without their disease getting worse (progression free survival) was 5.7 months for the DR group and 5.9 months for the BFR group.(1)

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SOURCE GlaxoSmithKline
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