Summary: Genmab and GlaxoSmithKline Have Completed Recruitment of 66 CLL Patients Respectively to Both Study Groups in a Pivotal Study of ofatumumab
COPENHAGEN, Denmark, November 28 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today recruitment of 132 patients has been completed in a pivotal study of ofatumumab (HuMax-CD20(R)) for the treatment of refractory chronic lymphocytic leukemia (CLL). This cohort comprises 66 patients who are refractory to both fludarabine and alemtuzumab and 66 fludarabine refractory patients who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. An interim analysis will be conducted on this cohort when 24 week efficacy data are available. The study will remain open for recruitment in order to collect additional safety and efficacy data.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of b-cells. This epitope is different to the other anti-CD20 antibodies currently available or in development. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
"We look forward to seeing the study results of the interim analysis from both patient groups. It is our hope, due to the high unmet need amongst these patients, that registration may be possible in each indication, depending on the data generated and ongoing discussions with the regulatory authorities. Recruitment will continue to the trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
About the study
The study includes CLL patients who are refractory to both fludarabine and alemtuzumab and patients who are refractory to fludarabine who are considered inappropriate candidates for alemtuzumab due to bulky tumor in their lymph nodes. Each group will be analyzed separately and it is hoped that, registration of ofatumumab may be possible in each indication, depending on the data generated from this study and the ongoing discussions with the regulatory authorities.
All patients in the study will receive 8 weekly infusions of ofatumumab, followed by 4 monthly infusions of ofatumumab. Patients will receive 300 mg of ofatumumab at the first infusion and 2,000 mg of ofatumumab at each subsequent infusion. Disease status will be assessed every 4 weeks until week 28 and then every 3 months until disease progression or month 24.
A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using unique, cutting-edge antibody technology, Genmab's world class discovery and development teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to up-date statements regarding the future following the publication of this release; nor to confirm such statements in relation to actual results, unless this is required by law.
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HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM);
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|SOURCE Genmab A/S|
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