Updated: August 9, 2007
Phase III Clinical Trial of Single-Agent HuMax-CD20
Seeking Approval on Different Fronts
In mid-2006 Genmab announced the launch of a second pivotal phase III clinical trial of HuMax-CD20 as a single agent: this time for treating follicular lymphoma patients who have failed chemoimmunotherapy combinations incorporating Rituxan or Rituxan given as maintenance therapy. While the trial is interesting in itself as expanding the options for follicular lymphoma patients, it also serves as another clinical platform to demonstrate the theoretically superior efficacy of HuMax-CD20 when compared to Rituxan. The results of this clinical trial should be of interest to CLL patients since approval for the treatment of follicular lymphoma would put HuMax-CD20 in an FDA approval status similar to that of Rituxan. Read the details in HuMax-CD20 Monotherapy in Refractory Follicular Lymphoma.
HuMax-CD20 plus Fludarabine plus Cyclophosphamide
Genmab's New Phase II H+FC Clinical Trial
Genmab has recently launched a chemoimmunotherapy combination clinical trial involving its anti-CD20 monoclonal antibody, HuMax-CD20 (generic name ofatumumab). This is a phase II dose comparison trial. The Genmab protocol combines HuMax-CD20 with fludarabine and cyclophosphamide over a 6 month treatment cycle. The trial is currently being offered at four recruitment centers in the United States. There is reason to hope that HuMax-CD20 will be more effective than Rituxan both as a single agent as well as in chemoimmunotherapy combinations such as this. You can find our discussion of this announcement at: HuMax+FC Announcement.
HuMax-CD20: Risks and Rewards
Belt, Suspenders and Cummerbund
Get to Know Ofatumumab
HuMax-CD20 derives part of its improved efficacy from its capacity to work with a patient's complement system to destroy B-cells. In HuMax-CD20 Risks and Rewards, we examine the potential risks of complement depletion that may accompany intensive treatment with this monoclonal antibody — and suggest a possible precautionary measure for those who are taking part in the Phase III trial of this agent for fludarabine- and Campath-refractory patients.
A Smarter Monoclonal on Trial
What Makes HuMax-CD20 Different from Rituxan?
In this article we take a closer look at the new agent starring in Genmab's recently announced Phase III clinical trial for fludarabine and Campath refractory CLL patients. This well-designed trial keys in on HuMax-CD20's strengths which we hope will provide significantly better results than singe-agent Rituxan, especially in this difficult patient cohort. To learn more about this pivotal trial and to understand how this important new monoclonal antibody works, read A Smarter Monoclonal on Trial.
Genmab in the News
HuMax-CD20 in Action
Harvey is Back!
We have an opportunity to see HuMax-CD20 in action when Harvey and Serena pack their bags and travel to England in pursuit of therapy with this new agent. To learn more, read: Genmab in the News.
HuMax Clinical Trial
Early Results from GenMab's Anti-CD20 Monoclonal Antibody
The Half-Full Glass
We have high hopes for the new generation of monoclonal antibodies that are under development and have discussed new trials under way to test these agents in the clinic. Early results form one such trial, involving GenMab's HuMax, were highlighted at the 2005 ASH conference in Atlanta. We offer our analysis of the published results in Results from GenMab's HuMax Clinical Trial.
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