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Alert Number 290

Humax-CD20 clinical trial results

Date: July 31, 2008

I do not generally forward company press releases to our members.  This one seemed to warrant an exception.  Many of you have been waiting to hear the results of the Humax-CD20 (“ofatumumab”) clinical trial results. This press release gives us a quick (and limited) peek at the results that will be more fully described at scientific meetings.

The trial recruited fludarabine refractory and Campath (alemtuzumab) refractory / or ineligible patients (ineligible because of bulky nodes) – in other words, the hardest nuts to crack as it were.  The treatment was single agent Humax-CD20.  I am pleased to see Humax-CD20 gave goodly overall responses and partial responses in this very refractory patient cohort.  To see the results in perspective, I doubt Humax-CD20’s direct competitor Rituxan would have been able to do much if anything at all.

I will bring you more details as they become available.

Be well,




Genmab and GlaxoSmithKline Announce Positive Top-Line Results In Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study

Summary: Phase III pivotal study of ofatumumab in refractory CLL meets primary endpoint.

Copenhagen, Denmark; July 31, 2008 – Genmab A/S (OMX: GEN) and GlaxoSmithKline (LSE and NYSE: GSK) announced today positive top-line results from an interim analysis of the Phase III pivotal study evaluating ofatumumab (HuMax-CD20 ) to treat two groups of chronic lymphocytic leukemia (CLL)  patients with high unmet medical need.  At the interim analysis, the study met the primary endpoint in both populations and the results from the secondary endpoints also support the primary endpoint.

The activity of ofatumumab was evaluated in154 patients in this interim analysis of whom 138 patients with refractory CLL were evaluable. About half of the patients (59) in the study were refractory to both fludarabine and alemtuzumab. The analysis also included a second group (79) who were refractory to fludarabine and considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes.  An objective response rate of 51% (p<0.0001) consisting of 30 partial responses (PR) was achieved in the group of patients refractory to patient fludarabine and alemtuzumab.  In the fludarabine refractory, alemtuzumab inappropriategroup, an objective response rate of 44% (p<0.0001) was achieved, including 1 complete response (CR), and 34 PR.  Achievement of the reported objective response rates are based on evaluations by an independent committee and are subject to review and confirmation by the regulatory authorities.

Ofatumumab was generally well tolerated by CLL patients in the study. The most frequently reported adverse events (those that occurred at a greater than 15% frequency) were: pyrexia, diarrhea, fatigue, cough, neutropenia, anemia and pneumonia.  There were no unexpected safety findings. None of the 14 patients tested for human anti-human antibodies (HAHA) demonstrated their presence at 12 months.


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