Healthcare Industry News: HER2
News Release - August 26, 2009
Genmab Announces Positive Top-Line Results for Arzerra(TM) in Front Line NHLGenmab announces positive top-line results from the Phase II study of Arzerra in combination with CHOP in front line follicular NHL
COPENHAGEN, Denmark, Aug. 26, 2009 -- (Healthcare Sales & Marketing Network) -- Genmab A/S (Copenhagen:GEN ) announced today positive top-line results from the Phase II study of Arzerra(TM) (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin's lymphoma (NHL).
A total of 58 patients were treated in the study. The overall response rate (ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse events of grade 3 or 4 (greater than 10 percent) were leucopenia and neutropenia. No events of sepsis or pneumonia were observed, and no deaths reported in the trial.
"We are pleased with the positive results shown in this study and believe they are indicative of the potential of ofatumumab in the treatment of front line follicular non-Hodgkin's lymphoma," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
About the study
Patients in this open label study were randomized into two dose groups of 29 patients each. Patients were to receive 300 mg of ofatumumab at the first infusion, followed by 5 infusions of either 500 or 1000 mg of ofatumumab every 3 weeks in combination with 6 cycles of CHOP. Disease status is measured prior to the fourth cycle, at three months following the last treatment and then every three months until month 12, and every six months thereafter until 24 months or initiation of alternative treatment. Treatment response was assessed according to the 1999 standardized response criteria for NHL by an Independent endpoints Review Committee.
The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study was objective response from start of treatment until 3 months after last administration of ofatumumab.
Ofatumumab is an investigational, fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.
Ofatumumab is not yet approved in any country.
Genmab will hold a conference call to discuss the ofatumumab results on August 27, 2009, at
The conference call will be held in English.
The dial in numbers are as follows:
+1 888 504 7953 (in the U.S.) and provide conference ID number 4575355
+1 719 457 2639 (outside the U.S.) and provide conference ID number 4575355
To listen to a live webcast of the call, visit www.genmab.com.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery, development and manufacturing teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit www.genmab.com.
This Stock Exchange 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. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward-looking statements in this Stock Exchange Release nor to confirm such statements in relation to actual results, unless required by law.
Genmab(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); HuMax-EGFr(tm); HuMax-IL8(tm); HuMax-TAC(tm); HuMax-HepC(tm); HuMax-CD38(tm); HuMax-CD32b(tm); HuMax-TF(tm); HuMax-HER2(tm); HuMax-VEGF(tm) and UniBody(r) are all trademarks of Genmab A/S. Arzerra(tm) is a trademark of GlaxoSmithKline.
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