Summary: GSK and Genmab announce top-line results from the concluded pivotal
trial of ofatumumab in patients with fludarabine-refractory CLL.
London, UK; Copenhagen, Denmark; August 9, 2010 - GlaxoSmithKline (GSK) and
Genmab A/S (OMX: GEN) announced today topline results from the concluded pivotal
trial of ofatumumab in patients with fludarabine and alemtuzumab refractory
chronic lymphocytic leukemia (CLL).
Ofatumumab was given accelerated approval by the US Food and Drug Administration
(FDA) on October 26, 2009 for the treatment of patients with CLL who are
refractory to fludarabine and alemtuzumab treatment based on the interim results
from this trial in 59 patients. On April 19, 2010, the European Commission
granted a conditional marketing authorization to Arzerra(TM) (ofatumumab) for
the treatment of chronic lymphocytic leukaemia (CLL) in patients who are
refractory to fludarabine and alemtuzumab.
A total of 95 patients with fludarabine and alemtuzumab refractory CLL were
treated in the study. The objective response rate (ORR), as determined by an
Independent Review Committee, in the study was 51%. In addition to the 95
patients in the efficacy analysis the study also included 128 patients with
relapsed or refractory CLL, who were not refractory to both fludarabine and
alemtuzumab.
There were no unexpected safety findings reported with the total study
population (n=223). The most common adverse reactions (≥10%) occurring in
patients treated with Arzerra were pyrexia (21%), anemia (18%), diarrhea (17%),
neutropenia, fatigue (16%), dyspnea (15%), pneumonia (15%), chills (13%), rash
(13%), nausea (13%), bronchitis (12%), peripheral edema (11%), back pain (10%)
and upper respiratory tract infection (10%).
Results from this concluded pivotal trial are consistent with the efficacy and
safety data reported in the interim analysis and demonstrate the activity of
single-agent ofatumumab in patients with heavily pretreated fludarabine and
alemtuzumab-refractory chronic lymphocytic leukemia.
About ofatumumab
Ofatumumab is a human monoclonal antibody. Ofatumumab binds specifically to
both the small and large extracellular loops of the CD20 molecule. The CD20
molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocytes)
and on B-cell CLL. In vitro data suggest that possible mechanisms of cell lysis
include complement-dependent cytotoxicity and antibody-dependent cell-mediated
cytotoxicity.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better, and live longer. For company
information, visit GlaxoSmithKline at http://www.gsk.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 and development 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); HuMax-Wnt; HuMax-cMet(TM) and
UniBody(R) are all trademarks of Genmab A/S. Arzerra(R) is a trademark of
GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com
Stock Exchange Release no. 27/2010
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GSK and Genmab Announce Topline Results from the Concluded Pivotal Trial of Arzerra (Ofatumumab) in Fludarabine and Alemtuzumab Refractory Chronic Lymphocytic Leukemia
| Source: Genmab A/S
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