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Alert Number 126

New Improved CD20 Monoclonal from Genmab

Date: September 16, 2005

Clinical Trial Results

We reviewed the GenMab Phase I / II clinical trial using their new improved anti-CD20 monoclonal drug in relapsed or refractory CLL patients. You can read the details in Sons of Rituxan and Campath and HuMax-CD20 - Improved Anti-CD20 Therapy?.

As we expected, enrollment in this trial was sold out in near record time. Some of us were disappointed at not being able to get in. But all of us are keeping our fingers crossed and rooting for the success of this one. The excitement is simply due to this: can we keep the low toxicity of Rituxan, since this drug too targets the same CD20 marker found only on mature B-cells, and because of better engineering improve the efficacy of the drug? Will HuMax-CD20 give us better bang for the buck? The company is publishing their results in the International World conference on CLL (IWCLL), September 16-18, 2005. You know me, I hate waiting. Here is the bottom-line scoop on the GenMab results.

I will be doing a full article on these results and other details of the GenMab paper in the next day or so. For now, the results are encouraging. Remember, these are relapsed and/or refractory patients, most of them had been through Rituxan and fludarabine prior to enrolling in this trial. In this crowd one would not expect too many CRs with plain vanilla Rituxan as single agent. Therefore, I am pleased that approximately one quarter of the patients got a CR. Not bad. But the devil is in the details, and you have to hold your horses for the next day or so. Today, I have to run some errands.

Be well,


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