Summary: Genmab has completed recruitment of patients in the zalutumumab
pivotal Phase III study in refractory head and neck cancer.
Copenhagen, Denmark; June 10, 2009 - Genmab A/S (OMX: GEN) announced today it
has completed enrollment of 273 patients in the zalutumumab pivotal Phase III
study in refractory head and neck cancer. Genmab expects to report final
results from the study by the end of 2009.
About the trial
The pivotal study includes patients with squamous cell carcinoma of the head and
neck (SCCHN) who are refractory to or intolerant of standard platinum-based
chemotherapy. Patients in the study are randomized into two treatment groups:
zalutumumab in combination with best supportive care or best supportive care
alone. Patients treated with zalutumumab in combination with best supportive
care receive an initial dose of 8mg/kg of zalutumumab, followed by weekly
infusions of a maintenance dose until disease progression. The maintenance dose
is adjusted as necessary until the patient develops a dose limiting skin rash,
up to a maximum dose of 16 mg/kg of zalutumumab. Disease status will be assessed
every 8 weeks by CT scan or MRI according to RECIST criteria until disease
progression and patients will be followed for survival.
The objective of the study is to evaluate the efficacy of zalutumumab in
combination with best supportive care as compared to best supportive care alone
in terms of overall survival. The primary endpoint in the study is overall
survival from randomization until death.
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.
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. 20/2009
###
